Form CMS-10631 PACE Application

The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)

PACE Paper Application_FINAL_01102022

Application Requirements (POs)

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PROGRAMS OF ALL-INCLUSIVE
CARE FOR THE ELDERLY
For all new applicants and existing PACE Organizations seeking to expand a service area

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services (CMS)
Center for Medicare (CM)
Medicare Drug and Health Plan Contract Administration
Group (MCAG)

PRA Disclosure Statement According to the Paperwork Reduction Act of 1995, no persons are required to
respond to a collection of information unless it displays a valid OMB control number. The valid OMB control
number for this information collection is 0938-1326. This is a voluntary information collection. The time required to
complete this information collection is estimated to average 81 hours and 51 hours per initial and service area
expansion response, respectively, including the time to review instructions, search existing data resources, gather
the data needed, and complete and review the information collection. If you have comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security
Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. ****CMS
Disclosure**** Please do not send applications, claims, payments, medical records or any documents
containing sensitive information to the PRA Reports Clearance Office. Please note that any
correspondence not pertaining to the information collection burden approved under the associated OMB
control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or
concerns regarding where to submit your documents, please send an inquiry to: https://PACE.lmi.org.

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Contents
1

2

3

GENERAL INFORMATION .............................................................. 4

1.1
1.2
1.3
1.4
1.4.1
1.5

Overview ..................................................................................................................... 4
Technical Support ....................................................................................................... 5
The Health Plan Management System (HPMS) ......................................................... 5
Submitting Notice of Intent to Apply (NOIA) ............................................................ 6
Protecting Confidential Information ........................................................................... 6
Application Determination and Appeal Rights ........................................................... 7

2.0
2.1
2.2
2.3
2.3.1
2.4

Overview ..................................................................................................................... 7
Types of Applications ................................................................................................. 8
Chart of Required Attestations and Uploads .............................................................. 8
Document (Upload) Submission Instructions ............................................................. 9
Document (Upload) Instructions Specific to SAE Applications .............................. 10
Part D Prescription Drug Benefit Instructions .......................................................... 10

3.0
3.1
3.2
3.3
3.4
3.4.1
3.4.2
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15
3.16
3.17
3.18
3.19
3.20
3.21
3.22

Administrative Requirements – Trial Period (SAE applicants only) ........................ 11
Service Area .............................................................................................................. 11
Legal Entity and Organizational Structure ............................................................... 12
Governing Body ........................................................................................................ 14
Fiscal Soundness ....................................................................................................... 15
Initial Application ..................................................................................................... 15
Service Area Expansion Application ........................................................................ 18
Marketing .................................................................................................................. 19
Explanation of Rights ............................................................................................... 21
Grievances................................................................................................................. 22
Service Determination Process ................................................................................. 23
Appeals ...................................................................................................................... 24
Enrollment................................................................................................................. 27
Disenrollment............................................................................................................ 30
Personnel Compliance .............................................................................................. 34
Program Integrity ...................................................................................................... 37
Contracted Services .................................................................................................. 37
Required Services ..................................................................................................... 39
Service Delivery........................................................................................................ 40
Infection Control ....................................................................................................... 41
Interdisciplinary Team .............................................................................................. 42
Participant Assessment ............................................................................................. 44
Plan of Care............................................................................................................... 47
Restraints................................................................................................................... 48
Physical Environment ............................................................................................... 49
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INSTRUCTIONS................................................................................. 7

ATTESTATIONS ............................................................................... 11

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3.23
3.24
3.25
3.26
3.27
3.28
3.29
3.30
3.31
3.32
3.33

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Emergency and Disaster Preparedness ..................................................................... 49
Transportation Services ............................................................................................ 50
Dietary Services ........................................................................................................ 51
Termination............................................................................................................... 52
Maintenance of Records & Reporting Data .............................................................. 53
Medical Records ....................................................................................................... 55
Quality Improvement Program ................................................................................. 56
State Attestations ...................................................................................................... 58
Waivers ..................................................................................................................... 60
Application Attestation ............................................................................................. 60
State Readiness Review ............................................................................................ 61

Document Upload Templates ............................................................ 61

4.1
Governing Body ........................................................................................................ 61
4.3
Subordinated/Guaranteed Debt ................................................................................. 62
4.4
Explanation of Rights ............................................................................................... 62
4.5
Enrollment................................................................................................................. 62
4.6
Additional Enrollment Criteria ................................................................................. 62
4.7
Voluntary Disenrollment .......................................................................................... 63
4.8
Involuntary Disenrollment ........................................................................................ 63
4.9
Grievances................................................................................................................. 63
4.10 Appeals ..................................................................................................................... 63
4.11 Additional Appeals Rights ........................................................................................ 64
4.12 Quality Improvement Program ................................................................................. 64
4.13 Medicare and State Medicaid Capitation Payment ................................................... 64
4.14 State Enrollment/Disenrollment Reconciliation Methodology................................. 67
4.15 Termination ............................................................................................................... 67
4.16 SAA Enrollment Process .......................................................................................... 67
4.17 SAA Oversight of PO Administration of Safety Criteria ......................................... 67
4.18 Information Provided by State to Participants .......................................................... 68
4.19 State Disenrollment Process ..................................................................................... 68
4.20 State Attestations/Assurances Signature Pages ........................................................ 68
4.21 Applicant Attestation ................................................................................................. 71
READINESS REVIEW REPORT........................................................................................ 72

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1.1

GENERAL INFORMATION
Overview

The Programs of All-Inclusive Care for the Elderly (PACE) is a pre-paid, capitated plan that
provides comprehensive health care services to frail, older adults in the community, who
are eligible for nursing home care according to State standards. PACE programs must
provide all Medicare and Medicaid covered services; financing of this model is
accomplished through prospective capitation of both Medicare and Medicaid payments.
CMS regulations at 42 CFR § 460.98(b) (2) require a PACE Organization (PO) to provide
PACE services in at least the PACE center, the home, and inpatient facilities. The PACE
center is the focal point for the delivery of PACE services; the Center is where the
interdisciplinary team (IDT) is located, services are provided, and socialization occurs with
staff that is consistent and familiar to participants. The PACE model of care includes, as core
services, the provision of adult day health care and interdisciplinary team (IDT) care
management, through which access to and allocation of all health services is managed.
Physician, therapeutic, ancillary and social support services are furnished in the participant’s
residence or onsite at a PACE Center. Hospital, nursing home, home health and other
specialized services are furnished in accordance with the PACE participant’s needs, as
determined necessary by the IDT. To provide PACE participants with flexibility regarding
access to quality care, CMS has allowed POs to offer some services in other settings which
are referred to as an alternative care setting (ACS). An ACS can be any physical location in
the PACE organization’s CMS approved existing service area other than the participant’s
home, an inpatient facility, or PACE center.
Section 4801 of the Balanced Budget Act of 1997 (BBA)(Pub. L. 105-33) authorized
coverage of PACE under the Medicare program by amending Title XVIII of the Social
Security Act (“the Act”) and adding section 1894, which addresses Medicare payments and
coverage of benefits under PACE. Section 4802 of the BBA authorized the establishment of
PACE as a state option under Medicaid by amending Title XIX of the Act and adding section
1934, which directly parallels the provisions of section 1894. The regulations implementing
these PACE statutory requirements are set forth in 42 CFR Part 460.
The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000,
(BIPA) amended the PACE statute to provide authority for CMS to modify or waive certain
PACE regulatory provisions. CMS-1201-IFC, Programs of All-inclusive Care for the
Elderly (PACE); Program Revisions, published October 1, 2002, 67 FR 61496,
established a process through which existing and prospective POs may request a waiver of
Medicare and Medicaid regulatory requirements. On December 8, 2003, the Congress enacted
the MMA of 2003 (Pub. L. 108-173). Several sections of the MMA impact POs. Most
notably, section 101 of the MMA affected the way in which POs are reimbursed for providing
certain outpatient prescription drugs to any Part D eligible participant. As specified in
sections 1894(b)(1) and 1934(b)(1) of the Act, POs shall provide all medically necessary
services including prescription drugs, without any limitation or condition as to amount,
duration, or scope and without application of deductibles, co-payments, coinsurance, or other
cost sharing that would otherwise apply under Medicare or Medicaid.
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In 2006, CMS issued a final rule (71 FR 71244, Dec 8, 2006) that finalized both the PACE
interim final rule with comment period published in the Federal Register November 24, 1999
(64 FR 66234) and the PACE interim final rule with comment period published in the Federal
Register on October 1, 2002 (67 FR 61496). For a complete history of the PACE program,
please see 71 FR 71244 through 71248 (Dec. 8, 2006). More recently, CMS issued a final
PACE rule (CMS-4168-F), effective August 2, 2019, which updates and modernizes the
PACE program. This final rule codified CMS’ existing practice of relying on automated
review systems for processing initial applications to become a PACE organization and
expansion applications for existing PACE organizations. In addition, the final rule modified
the PACE regulations to eliminate the need for PACE organizations to request waivers for a
number of the most commonly waived provisions.
CMS Subsequently finalized a PACE rule (CMS-4190-F2 (86 FR 5864), applicable January
1, 2022. This rule largely impacts the participant rights aspect of the application by adding 3
new distinct rights as well as requirements related to participant appeals. The rule also
includes new service determination request provisions, which enable PACE participants to
request initiation of a service, modification of an existing service or continuation of a service
that a PACE organization recommends to be discontinued or reduced.
1.2

Technical Support

CMS provides training information available on the CMS website at:
https://www.cms.gov/Medicare/Health-Plans/PACE/Overview. This includes both an
overview of the PACE application process as well as training to assist applicants with
navigating the Health Plan Management System (HPMS), which is the system used by
applicants to prepare and submit their electronic applications. All applicants are
strongly encouraged to view these trainings prior to initiating the application process.
CMS Central Office (CO) staff are available to provide Health Plan Management System
(see Section 1.3, below) technical support to all applicants and answer questions during the
PACE application process. While preparing the application, applicants may send inquiries
to the PACE portal at: https://PACE.lmi.org. Please note: this is a webpage, not an email
address.
1.3

The Health Plan Management System (HPMS)
HPMS is the primary information collection vehicle through which PACE applicants
will communicate with CMS during the application process, the Part D bid submission
process, and for reporting and oversight activities.
Applicants are required to enter contact and other information in HPMS in order to
facilitate the application review process. Applicants must promptly enter organizational
data into HPMS and keep the information up to date. These requirements ensure that
CMS has current information and is able to provide guidance to the appropriate
contacts within the organization. In the event that the application is approved and CMS
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executes a 3-way program agreement with the applicant entity and the applicable State,
this contact information will also be used for frequent communications during the
operational period of the PACE program. Therefore, it is important that this
information be accurate at all times.
HPMS is also the vehicle used to disseminate CMS guidance to POs. This
information is then incorporated into the appropriate manuals. It is imperative for
POs to independently check HPMS memos and follow the guidance as indicated in
the memos.
1.4

Submitting Notice of Intent to Apply (NOIA)

Organizations interested in becoming a new PO must complete a nonbinding NOIA in
order to submit an initial PACE application to be approved as a PACE organization. The
NOIA form is available on the CMS website at: https://www.cms.gov/Medicare/HealthPlans/PACE/Overview. The completed form must be submitted to the PACE portal at:
https://PACE.lmi.org.
To ensure adequate time for processing, applicants should submit the completed NOIA to
the PACE portal during the first month of the quarter in which the applicant intends to
submit the application. (Applications must be created, completed and submitted within
the same quarter to HPMS.) NOIAs that are not submitted timely may result in an
organization’s inability to submit the application during the desired quarterly cycle. Upon
submission of the completed NOIA form to CMS, the organization will be assigned a
pending contract number (H number) to use throughout the application and subsequent
operational processes. This contract number starts with an H and is followed by 4 numbers
(Hxxxx).
Once a contract number is assigned, the applicant should request a CMS User ID, which is
needed to access CMS systems. To request a user ID, follow the “Instructions for
Requesting Plan Access via EFI” link in the Downloads section of the following website:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-andSystems/HPMS/UserIDProcess.html. This process may take 2-4 weeks, so applicants must
allow sufficient time to obtain access and complete the application prior to the quarterly
submission deadline. Upon approval of the CMS User ID request, the applicant will
receive a CMS User ID(s) and password(s) for HPMS access.
Note that a NOIA is not required of existing, operational PACE organizations that seek to
submit an expansion application. However, expansion applicants should inform their
Regional Office Account Managers of any plans to submit a service area expansion
application.
1.4.1

Protecting Confidential Information

Applicants may seek to protect their information from disclosure under the Freedom of
Information Act (FOIA) by claiming that FOIA Exemption 4 applies. The applicant is
required to label the information in question “confidential” or “proprietary” and explain
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the applicability of the FOIA exemption it is claiming. When there is a request for
information that is designated by the applicant as confidential or that could reasonably be
considered exempt under FOIA Exemption 4, CMS is required by its FOIA regulation at
45 CFR 5.65(d) and by Executive Order 12600 to give the submitter notice before the
information is disclosed. To decide whether the applicant’s information is protected by
Exemption 4, CMS must determine whether the applicant has shown that: (1) disclosure
of the information might impair the government’s ability to obtain necessary information
in the future; (2) disclosure of the information would cause substantial harm to the
competitive position of the submitter; (3) disclosure would impair other government
interests, such as program effectiveness and compliance; or (4) disclosure would impair
other private interests, such as an interest in controlling availability of intrinsically
valuable records, which are sold in the market place. Consistent with our approach under
other Medicare programs, CMS would not release information that would be considered
proprietary in nature if the applicant has shown it meets the requirements for FOIA
Exemption 4.
1.5

Application Determination and Appeal Rights

Pursuant to 42 CFR §460.20, if CMS denies an application, CMS must notify the entity in
writing of the basis for the denial and the process for requesting reconsideration of the denial.

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2.0

INSTRUCTIONS
Overview

Applicants must complete the PACE initial and service area expansion (SAE) application
using HPMS as instructed. All documentation must contain the appropriate CMS-issued
contract (“H”) number. Applications are accepted on a quarterly basis, on a designated day,
which is generally the last Friday in March, June, September and December, with possible
modification to account for a holiday. While applications may be created at any time during
a specific quarterly cycle, the completed application (i.e., attestation responses and all
uploaded documentation, as required) may not be transmitted until the applicant hits the
“Final Submit” button on the designated day. CMS provides the submission dates for a
given year through an HPMS blast or email in the early part of the year and includes an
announcement in HPMS to indicate when the next cycle applications are due.
In preparing a response to the prompts throughout this application, the applicant must
mark “Yes” or “No” or “N/A” in sections organized with that format. By responding
“Yes,” the applicant is certifying that its organization complies with the relevant
requirements as of the date the application is submitted to CMS, unless a different date is
stated by CMS.
Throughout this application, applicants are asked to provide various documents in HPMS.
All required documents to be submitted are specified at the end of each attestation section;
a chart of all required attestations and uploads associated with initial and SAE applications
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is also included in Section 2.2.
CMS strongly encourages PACE applicants to refer to the regulations at 42 CFR §460.
Nothing in this application is intended to supersede the regulations at 42 CFR §460. Failure
to reference a regulatory requirement in this application does not affect the applicability of
such requirement; applicants are required to comply with all applicable requirements of the
regulations. Applicants must read HPMS memos and visit the CMS website periodically to
stay informed about new or revised guidance documents.
2.1

Types of Applications

Initial Applications are for:
•

Applicants who are seeking to become a PACE organization for the first time.

Service Area Expansion Applications are for:
•

Existing PACE organizations who are seeking to expand the service area of an existing
contract number. This includes an expansion of the currently-approved geographic
service area and/or the addition of a new PACE center site.

2.2

Chart of Required Attestations and Uploads

This chart (Chart 1) describes the required attestations and uploads for both initial
PACE and SAE applications. Note that SAE applicants must generally respond to the
same attestations, as well as upload all documents required of initial applicants. (See
Section 2.3.1, below, regarding upload submission instructions and information
specific to SAE applications.) The purpose of this chart is to provide the applicant
with a summary of the attestation topics.
Chart 1 - Required Attestations and Uploads
Attestation Topic

Section #

Service Area

3.1

Legal Entity and Organizational Structure

3.2

Governing Body

3.3

Fiscal Soundness

3.4

Marketing

3.5

Explanation of Rights

3.6

Grievance

3.7

Service Determination Process

3.8

Appeals

3.9

Enrollment

3.10

Initial

SAE

Upload
Required
(Initial)

Upload
Required
(SAE)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

*

X

X

X**

X**
(as
applicable)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

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Attestation Topic

Section #

Disenrollment

3.11

Personnel Compliance

3.12

Program Integrity

3.13

Contracted Services

3.14

Required Services

3.15

Service Delivery

3.16

Infection Control

3.17

Interdisciplinary Team

3.18

Participant Assessment

3.19

Plan of Care

3.20

Restraints

3.21

Physical Environment

3.22

Emergency and Disaster Preparedness

3.23

Transportation Services

3.24

Dietary Services

3.25

Termination

3.26

Maintenance of Records & Reporting Data

3.27

Medical Records

3.28

Quality Improvement Program

3.29

State Attestations

3.30

Waivers

3.31

Application Attestations

3.32

State Readiness Review

3.33

Initial

SAE

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Upload
Required
(Initial)

Upload
Required
(SAE)

X

X

X

X

X

X

X

X

X

X

X

X

X

X
(as
applicable)

X
(as
applicable)

X

X

X

X

X

X

X***

X***
(as
applicable)

* Financial documentation is not a requirement of SAE applicants. However, applicants may be asked to
provide specific information as part of the Request for Additional Information (RAI) process if CMS is unable
to verify that the applicant is maintaining a fiscally sound operation.
** Marketing materials for both initial and SAE applications are captured separately, via the HPMS PACE
marketing module. Applicants must upload marketing materials in the HPMS marketing module for CMS/State
review and approval following application submission. Additional information regarding the marketing
materials associated with an application may be found in Section 3.5 of this application.
*** The State Readiness Review is required, but may or may not be uploaded as part of the initial submission
of the application; the State Readiness Review may be uploaded after the initial application submission,
subsequent to CMS’s request for additional information.

2.3

Document (Upload) Submission Instructions

Required upload documents must generally be grouped together in a zipped file before
uploading. The Readme files for both the PACE and Part D applications (found in the
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appropriate download templates) details which files to group together and which are to be
uploaded individually. Note that each succeeding upload overwrites any previous
upload. Therefore, when re-uploading a grouped file, applicants MUST include ALL files in
the group in the re-upload.
In addition, the Readme Files provide Naming Conventions for uploaded files. PACE
applicants must use these naming conventions, where applicable, and be sure to include the
assigned H number in the file name of all submitted documents.
2.3.1

Document (Upload) Instructions Specific to SAE Applications

Generally, the same attestation and upload requirements are required of both initial and SAE
applicants. One key exception is Section 3.4 (Fiscal Soundness), which includes different
attestation requirements for initial and SAE applicants. In addition, while there is no required
financial upload for a PACE SAE application, an applicant may be asked to provide specific
information as part of a request for additional information. Documentation submitted in
conjunction with initial and SAE applications will be reviewed and incorporated as part of the
amended program agreement following approval of the application.
All applicants must upload a “State Attestations” document provided by an authorized official
of the State Administering Agency (SAA) to demonstrate that the SAA supports the
application. All initial applications and any SAE application that includes the addition of a
new PACE center require a State Readiness Review (SRR) of the new center. Note that SAE
applications that do not include a new PACE center site generally do not require a readiness
review; however, the SAA must consider whether the existing PACE center has the capacity
to adequately serve new potential participants who reside in the proposed expanded
geographic area. SAAs may vary in their requirements for approval of the SAE under these
circumstances.
NOTE regarding SAE applications: Active PACE organizations may not submit a service
area expansion application if an application is currently pending. PACE organizations that
seek to submit another expansion application must wait until CMS has made a final
determination regarding the pending application before submitting another as part of a
subsequent quarterly cycle. Therefore, organizations should carefully consider expansion
proposals and plan accordingly when submitting expansion applications.
2.4

Part D Prescription Drug Benefit Instructions

The Medicare Part D Application is to be completed by those newly forming POs that
intend to provide the Part D benefit to eligible participants. Applicants must use the current
Medicare Part D Application for new POs that can be accessed via the link below. CMS
will not accept or review in any way those submissions using prior versions of the
application.
The Medicare Part D Application for new POs can be found at:
http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugC
ovContra/RxContracting_ApplicationGuidance.html.
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The Part D application must be submitted simultaneously with this PACE application
and both will be reviewed within the same timeframes.

3 ATTESTATIONS
3.0

Administrative Requirements – Trial Period (SAE applicants only)

The purpose of this section is to ensure that SAE applicants have successfully completed the
first trial period audit in order to be able to proceed with the submission of a SAE application
consistent with the requirements of 42 CFR §460.12.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO THE FOLLOWING
STATEMENT: TRIAL PERIOD

YES

NO

1. Applicant acknowledges that the first trial period audit has
been successfully completed.
(If the response is “No,” the applicant may not proceed with
the SAE application because CMS and the State
Administering Agency will only approve a service area
expansion or PACE center site expansion after the PACE
organization has successfully completed its first trial period
audit and, if applicable, has implemented an acceptable
corrective action plan per 42 CFR §460.12(d).)

3.1

Service Area

The purpose of this section is to ensure that all PACE applicants define the proposed
geographic area that will be served consistent with the requirements of 42 CFR §460.12,
§460.70, and §460.98.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: SERVICE AREA

YES

NO

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1. Applicant ensures that contracted services are
accessible to participants and located near or within
the geographic service area as specified in
§460.70(b)(2).
2. Applicant agrees to operate at least one PACE center
within or contiguous to the geographic service area
with capacity to allow routine attendance by
participants as specified in §460.98(d)(1).
B. In HPMS, on the Contract Management/Contract Service Area/Service Area Data
page, enter the state and county information for the area the Applicant proposes to
serve.
C. In the Documents Section, upload a detailed map, with a scale of the complete
geographic service area that includes county, zip code, street boundaries, census tract
or block or tribal jurisdiction and main traffic arteries, physical barriers such as
mountains and rivers and location of the PACE center (including the address of the
PACE center facility), hospital providers, ambulatory and institutional services sites.
Depict on the map the mean travel time from the farthest points on the geographic
boundaries to the nearest ambulatory and institutional service sites. Service area
expansion applications that include a geographic expansion must clearly distinguish
the proposed expansion area from the currently-approved service area.
Note: The map must be developed in accordance with 42 CFR §460.12, §460.70, and
§460.98.
3.2

Legal Entity and Organizational Structure

The purpose of this section is to ensure that all PACE applicants are organized under State
law and have a current chart outlining the organizational structure consistent with the
requirements of 42 CFR §460.60.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: LEGAL ENTITY
AND ORGANIZATIONAL STRUCTURE

YES

NO

N/A

1. Applicant ensures that the corporate entity that signs the
Program Agreement has the legal authority to do so.
2. Applicant agrees that the Program Director is
responsible for oversight and administration of the entity
(§460.60(a)).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: LEGAL ENTITY
AND ORGANIZATIONAL STRUCTURE

YES

NO

N/A

3. Applicant agrees that the Medical Director is responsible for
delivery of participant care, clinical outcomes and
implementation and oversight of the quality improvement
program (§460.60(b)).
4. Applicant agrees to maintain an up-to-date organizational
chart indicating the persons and titles of all officials in the PO
(§460.60(c)).
5. Applicant agrees to indicate relationships to the corporate
board, parent, affiliates, and subsidiary corporate entities
in an organizational chart.
Note: If the applicant is not part of a corporate entity, then the
applicant should respond "N/A".
6. Applicant agrees to notify CMS and SAA in writing at least
14 days before a change in the organizational structure
takes effect (§460.60(c)(3)).
7. For any planned change in ownership, the applicant agrees
to comply with all requirements in 42 CFR part 422,
subpart L, and must notify CMS and the SAA, in writing, at
least 60 days before the anticipated effective date of the
change (§460.60(d)).
8. Applicant ensures that they are organized to operate within
the state consistent with all applicable state laws.
9. If planning to do business as (d.b.a.) under a name that is
different from the name of the organization, applicant
attests that it has state approval for the d.b.a.
B. In the Documents Section, upload a description of the organizational structure of the
PO, including the relationship to, at a minimum: the governing body, program
director, medical director, and to any parent, affiliate or subsidiary entity.

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3.3

Governing Body

The purpose of this section is to ensure that all PACE applicants have appropriate resources
and structures available to effectively and efficiently manage administrative issues associated
with PO operations and participant concerns consistent with the requirements of 42 CFR
§460.62.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: GOVERNING
BODY
1. Applicant ensures operation under an identifiable
governing body such as a board of directors or a
designated person functioning as such who
provides oversight and authority for the following
functions:

YES

NO

• Governance and operation;
• Development of policies consistent with its
mission;
• Management and provision of all services,
including the management of subcontractors;
• Personnel policies (that address adequate notice of
termination by employees or contractors with direct
participant care responsibilities);
• Fiscal operations;
• Development of policies on participant health and
safety; and
• Quality improvement program.
(see §460.62(a)(7))
2. Applicant ensures a Participant Advisory
Committee is established of which the majority
consists of participants and participant
representatives who advise the governing body on
participant concerns and provide them with meeting
minutes that include participant issues
(§460.62(b)).
3. Applicant agrees to appoint a participant
representative to act as a liaison between the
governing body and Participant Advisory
Committee, to present participant issues to the
governing body and to ensure community
representation (§460.62(c)).
B. In the Documents Section, upload a current list of the governing body members/board of
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directors and their titles and indicate which members are PACE participant
representative(s). Include the name and phone number of a contact for the governing
body and the name and phone number of the PACE Program Director responsible for
oversight and administration as described in §460.60(a).
3.4

Fiscal Soundness

3.4.1 Initial Application
The purpose of this section is to ensure that all PACE applicants meet the financial
requirements consistent with 42 CFR §460.80, §460.204, and §460.208.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: FISCAL SOUNDNESS
1. Applicant agrees to maintain a fiscally sound operation as
specified in 42 CFR §460.80(a)(1-3):
• Total assets greater than total unsubordinated liabilities;
• Sufficient cash flow and adequate liquidity to meet
obligations as they become due; and
• A net operating surplus or a financial plan for maintaining
solvency that is satisfactory to CMS and the State
administering agency (SAA).
2. Applicant agrees to provide CMS a copy of the signed
“Subordinated/Guaranteed Debt Attestation” form for each
financial reporting period.

YES

NO

N/A

3. Applicant agrees to upload a documented plan in the event of
insolvency as specified in 42 CFR §460.80(b).

4. Applicant agrees to provide CMS and the SAA accurate
financial reports as specified in 42 CFR §460.204.
5. Applicant agrees to submit quarterly and annual certified
financial statements in a format acceptable to CMS and the
SAA as specified in 42 CFR §460.208.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: FISCAL SOUNDNESS
6. Applicant agrees to provide any reserve requirements and
other financial requirements set by the State in which the
applicant proposes to operate its PACE program, and any
supporting documentation necessary to demonstrate how the
applicant meets these requirements.

YES

NO

N/A

B. In the Documents Section, upload the independently audited financial statements
for the three most recent fiscal year periods or, if operational for a shorter period
of time, for each operational fiscal year.
Note: If the PACE legal entity (applicant) is a line of business of the parent
organization, and audited annual financial statements are not available at the
PACE legal entity level, the applicant may provide audited statements relating to
the parent organization. The applicant may also upload independently audited
financial statements of guarantors and lenders (e.g. organizations providing loans,
letters of credit or other similar financing arrangements, excluding banks), if
audited financial statements are not available for either the legal entity or the
parent organization.
Audits provided in the Documents section of the application, must include:
• Opinion of a certified public accountant;
• Statement of revenues and expenses;
• Balance sheet;
• Statement of cash flows;
• Explanatory notes; and
• Statements of changes in net worth.
C. In the Documents Section, upload the most recent year-to-date unaudited financial
statements of the PACE applicant legal entity, or if unavailable, for the parent
organization, guarantors or lenders.
D. In the Documents Section, upload financial projections.
Note: Provide financial projections beginning with program commencement
through one year beyond break-even. (Financial projections should be prepared
using the accrual method of accounting in conformity with generally accepted
accounting principles (GAAP). Prepare projections using the pro-forma financial
statement methodology. For a line of business, assumptions need only be
submitted to support the projections of the line.) Projections must include:
•

Opening and annual balance sheet
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•
•

•

Quarterly statements of revenues and expenses for legal entity
Projections in gross dollars which include year-end totals. (In cases
where the plan is a line of business, the applicant should also complete
a statement of revenue and expenses for the line of business).

Statement and justification of assumptions
• State major assumptions in sufficient detail to allow an independent
financial analyst to reconstruct projected figures using only the stated
assumptions;
• Include operating and capital budget breakdowns;
• Address all periods for which projections are made and include
inflation assumptions;
• Justify assumptions to the extent that an independent financial analyst
would be convinced that they are reasonable; and
• Base justification on such factors as the applicant's experience and the
experience of other POs.

E. In the Documents Section, upload the Subordinated/Guaranteed Debt Attestation
form (if applicable).
Note: Subordinated debt is defined as an unsecured debt whose repayment to its
parent organization ranks after all other debts have been paid when the subsidiary
files for bankruptcy. Guaranteed debt is defined as secured debt in which another
entity promises to pay a loan or other debt if the organization that borrowed the
money fails to pay. If subordinated/guaranteed debt is identified by the PACE
organization (legal entity), it should be included in the total PACE liabilities and
the amount of subordinated/guaranteed debt must be clearly identified on the
balance sheet of the financial statements and financial projections (if applicable).
Please submit a detailed description, including the name and nature of the
subordinated/guaranteed debt amount.
F. In the Documents Section, upload your Insolvency Plan.
G. In the Documents Section, upload documents that demonstrate the applicant can,
in the event it becomes insolvent, cover expenses of at least the sum of one
month's total capitation revenue to cover expenses the month prior to insolvency
and one month's average payment to all contractors, based on the prior quarter's
average payment, to cover expenses the month after the date insolvency is
declared or operations cease. (Arrangements to cover expenses may include, but
are not limited to, insolvency insurance or reinsurance, hold harmless
arrangements, letters of credit, guarantees, net worth, restricted state reserves or
State law provisions.) (42 CFR §460.80)
H. In the Documents Section, upload a description of any reserve requirements and
other financial requirements set by the State and supporting documentation to
demonstrate how the applicant meets these requirements (if applicable).
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3.4.2 Service Area Expansion Application
The purpose of this section is to ensure that all PACE applicants meet the financial
requirements consistent with 42 CFR §460.80, §460.204, and §460.208. CMS reserves the
right to request additional financial information such as the most recent audited annual
financial statements and most recent unaudited financial statements, as it sees fit to determine
if the applicant is maintaining a fiscally sound operation.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: FISCAL SOUNDNESS
1. Applicant maintains a fiscally sound operation as specified
in 42 CFR §460.80(a)(1-3):
• Total assets greater than total unsubordinated liabilities;
• Sufficient cash flow and adequate liquidity to meet
obligations as they become due; and
• A net operating surplus or a financial plan for maintaining
solvency that is satisfactory to CMS and the State
administering agency (SAA).

YES

NO

N/A

Note: CMS will confirm the attestation response by reviewing the most recent audited
annual financial statements submitted by the applicant through the Fiscal Soundness Module
in HPMS. If the most recent audited annual financial statements in the HPMS fiscal
soundness module do not demonstrate that the applicant is maintaining a fiscally sound
operation by at least maintaining total assets greater than total unsubordinated liabilities, the
applicant must demonstrate that it is meeting fiscal soundness requirements and upload either:
1. The final audited annual financial statements for the most recent fiscal year end,
demonstrating the applicant is maintaining a fiscally sound operation by at least maintaining a
positive net worth (total assets greater than total unsubordinated liabilities) in accordance with
42 CFR Section 460.80(a)(1); or
2. The most recent quarterly or annual financial statements and include an opinion (such as a
letter, not a full audit) from the applicant's independent auditor confirming that the
organization's most recent quarterly or annual financial statements are meeting CMS's fiscal
soundness requirement by at least maintaining a positive net worth (total assets exceed total
unsubordinated liabilities) in accordance with 42 CFR Section 460.80(a)(1).
B. In the Documents Section, upload the most recent independently audited financial
statements.
Audits provided in the Documents section of the application, must include:
• Opinion of a certified public accountant;
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• Statement of revenues and expenses;
• Balance sheet;
• Statement of cash flows;
• Explanatory notes; and
• Statements of changes in net worth.
C.

In the Documents Section, upload the most recent year-to-date unaudited financial
statements of the PACE legal entity.

3.5

Marketing

The purpose of this section is to ensure that all PACE applicants develop a plan for marketing
and marketing materials consistent with the requirements of 42 CFR §460.82 and the PACE
Marketing Guidelines.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: MARKETING

YES

NO

1. Applicant agrees to follow PACE Marketing
Guidelines when informing the public about its
program and giving prospective participants written
information on the following:
• Description or list of benefits and services;
• Description of premiums or other payment
responsibilities; and
• Other information necessary for prospective
participants to make an informed decision about
enrollment.
2. Applicant agrees that the following information on
restriction in services is included in their marketing
materials:
• Participant must receive all needed health care,
including primary care and specialist physician
services (other than emergency services), from the
PO or from an entity authorized by the PO; and
• Participants may be fully and personally liable for
the costs of unauthorized or out-of-network services.
3. Applicant agrees that the marketing material is free
of inaccuracies, misleading information, or
misrepresentations.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: MARKETING

YES

NO

4. Applicant agrees to make marketing materials
available to prospective and current participants in
English and in any other principal languages of the
community as determined by the State in which the
PACE organization is located (in the absence of a
State standard, a principal language of the
community is any language that is spoken by at least
5 percent of the individuals in the PACE
organization's service area), and in Braille, if
necessary, per 42 CFR §460.82(c).
5. Applicant agrees to submit marketing material, as
outlined in the PACE Marketing Guidelines, to the
HPMS module and obtain CMS Regional Office and
SAA approval of all marketing information before
distribution.
6. Applicant agrees that its employees or agents will not use the
following prohibited marketing practices in accordance with 42
CFR 460.82(e):
• Discrimination of any kind, except that marketing may be
directed to individuals eligible for PACE by reason of their age;
• Activities that could mislead or confuse potential participants
or misrepresent the PO, CMS, or the SAA;
• Gifts or payment to induce enrollment;
•Marketing by any individual or entity that is directly or
indirectly compensated by the PACE organization based on
activities or outcomes unless the individual or entity has been
appropriately trained on PACE program requirements; and
• Unsolicited door-to-door marketing.
7. Applicant agrees that its employees or agents will not use any
marketing practices that are prohibited according to PACE
regulation at 42 CFR §460.82.

NOTE: PACE organizations may begin submitting marketing materials for review after the
application has been submitted and the PACE organization gains access to the HPMS
Marketing Module. If a PACE organization does not have an executed contract with CMS,
any submitted and approved marketing materials will be considered as conditionally
approved, pending the outcome of the application review. Initial PACE applicants may not
begin marketing until they have been approved and have received a copy of their program
agreement signed by all parties; SAE applicants may not begin marketing in the expanded
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geographic area, as applicable, until the SAE has been approved and the PACE organization
has received the amended program agreement.
3.6

Explanation of Rights

The purpose of this section is to ensure that all PACE applicants have a Participant Bill of
Rights, and policies and procedures consistent with the requirements of 42 CFR §460.82,
§460.110, §460.112, §460.116, and §460.118.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: EXPLANATION OF RIGHTS

YES

NO

1. Applicant's policies and procedures ensure that the participant,
his or her representative, if any, understand their participant
rights as specified in §460.110, §460.112, §460.116, and
§460.118.
2. Applicant's policies and procedures ensure that staff (employed
and contracted) are educated and understand participant rights
as specified in §460.110 §460.112, §460.116, and §460.118.
3. Applicant agrees to explain the rights to the participant at the
time of enrollment in a manner understood by the participant as
specified in §460.110(b), §460.112, and §460.116(b).
4. Applicant agrees to meet the following requirements:
• Write the participant's rights in English and in any other
principal languages of the community as determined by the
State in which the PACE organization is located (in the absence
of a State standard, a principal language of the community is
any language that is spoken by at least 5 percent of the
individuals in the PACE organization's service area), and in
Braille, if necessary, per §460.82(c); and
• Display the PACE participant's rights in a prominent place in
the PACE center as specified in §460.116(c).
5. Applicant ensures that their procedures respond to and rectify a
violation of a participant's rights in §460.118.
6. Applicant agrees to explain advance directives to participants,
and establish them, if the participant so desires, as specified in
460.112(e)(2).
B. In the Documents Section, upload a copy of your Participant Bill of Rights. Please note
the PACE Participant Rights template document, which may be found at:
https://www.cms.gov/Medicare/Health-Plans/PACE/Overview.
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3.7 Grievances
The purpose of this section is to ensure that all PACE applicants have a formal written
process for participants, their family members or representatives to express dissatisfaction
with service delivery or the quality of care furnished consistent with the requirements of 42
CFR §460.120.
A. In HPMS, complete the table below:
YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: GRIEVANCES

YES

NO

1. Applicant agrees to have a formal written process to evaluate
and resolve medical and non-medical grievances by participants,
their family members, or representatives, that includes the
following:
• How a participant files a grievance;
• Documentation of a grievance;
• Response to and resolution to a grievance in a timely manner;
and
• Maintenance of confidentiality of the grievance (see
§460.120(c)).
2. Applicant agrees to document all expressions of dissatisfaction
with service delivery or quality of care furnished, whether
written or oral.
3. Applicant agrees to provide participants with written
information of the grievance process upon enrollment, and at
least annually thereafter (§460.120(b)).
4. Applicant agrees to furnish all required services to participants
during the grievance process (§460.120(d)).
5. Applicant agrees to discuss with and provide to the participant
in writing the specific steps that will be taken to resolve the
grievance, including timeframes for a response (§460.120(e)).
6. Applicant agrees to maintain, aggregate and analyze information
on grievance proceedings, and use this information in the
internal quality improvement program (§460.120(f)).
B. In the Documents Section, upload a copy of your policies and procedures for
grievances. Note the policies and procedures should specify whether the timeframes
for responding to grievances are calendar days or business days.

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3.8 Service Determination Process
The purpose of this section is to ensure that all PACE applicants have procedures for
identifying and processing service determination requests in accordance with the
requirements at 42 CFR §460.121.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: APPEALS

YES

NO

1. Applicant agrees to have formal written procedures for identifying
and processing service determination requests consistent with
specific requirements at §460.121(a).
2. Applicant agrees to accept service delivery determination
requests from the participant, participant’s designated
representative, or participant’s caregiver either orally or in
writing (§460.121(c) and §460.121(d)(1)).
3. Applicant agrees that an individual may make a service
determination request to any employee or contractor that
provides direct care to the participant in the participant's
residence, the PACE center, or while transporting the
participant (§460.121(d)(2)).
4. Applicant agrees to process service determination requests in
accordance with §460.121(e) – (i) and §460.121(l).
5. Applicant agrees to provide the participant or the designated
representative with notification of the decision as required in
§460.121(j).
6. Applicant agrees to provide the approved service as expeditiously
as the participant's condition requires, taking into account the
participant's medical, physical, emotional, and social needs in
accordance with (§460.121(k)).
7. Applicant agrees to establish and implement a process to document,
track, and maintain records related to all processing requirements
for service determination requests received both orally and in
writing. These records must be available to the interdisciplinary
team to ensure that all members remain alert to pertinent participant
information (§460.121(m)).
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3.9 Appeals
The purpose of this section is to ensure that all PACE applicants have a formal written
appeals process consistent with the requirements 42 CFR, §460.122, and §460.124.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: APPEALS

YES

NO

1. Applicant agrees to have a formal written process, with
specified timeframes for response, to address non coverage of
or nonpayment of a service, that includes, at a minimum,
procedures for the following, as specified in §460.122(a), and
42 CFR §460.122(c):
• Written denials of coverage or payment are prepared and
processed timely, as provided in §460.122(c)(1);
• How a participant or designated representative files an
appeal, including procedures for accepting oral and written
appeal requests, per §460.122(c)(2);
• Documentation of participant's appeal per §460.122(c)(3);
• Review of an appeal by an appropriate third party reviewer or
committee, per §460.122(c)(4);
• The distribution of written or electronic materials to the third
party reviewer or committee as specified in §460.122(c)(5);
• Responses to, and resolution of, appeals as expeditiously as
the participant's health condition requires, but no later than 30
calendar days after the organization receives an appeal, per
§460.122(c)(6); and
• Maintenance of confidentially of appeals, per §460.122(c)(7).
2. Applicant agrees to provide participants written information
on the appeals process upon enrollment, at least annually
thereafter, and whenever the interdisciplinary team (IDT)
denies a service determination request or request for
payment as specified in §460.122(b) and §460.124.
3. Applicant agrees give all parties involved in the appeal a
reasonable opportunity to present evidence related to the
dispute in person, and in writing as specified in
§460.122(d).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: APPEALS

YES

NO

4. Applicant agrees to furnish the disputed services to
Medicaid participants until issuance of the final
determination, if the following conditions are met as
specified in 42 CFR §460.122(e)(1):
• The PO is proposing to terminate or reduce services
currently being furnished to the participant; and
• The participant requests continuation of the service with
the understanding that he or she may be liable for the costs
of the contested service if the determination is not made in
his or her favor.
5. Applicant agrees to furnish all other required services to the
participant during the appeals process as specified in
§460.122(e)(2).
6. Applicant agrees to have an expedited appeals process for
situations in which the participant believes that his or her life,
health, or ability to regain or maintain maximum function could
be seriously jeopardized, absent provision of the service in
dispute as specified in §460.122(f)(1).
7. Applicant agrees to respond to an expedited appeal as
expeditiously as the participant's health condition requires, but
no later than 72 hours after the organization receives the appeal
as specified in 42 CFR §460.122(f)(2).
8. Applicant agrees to make its participants aware that the
applicant can extend the 72-hour timeframe for an expedited
appeal by up to 14 calendar days for either of the following
reasons as specified in §460.122(f)(3):
• The participant requests the extension; and
• The organization justifies to the SAA the need for additional
information and how the delay is in the interest of the
participant.
9. Applicant agrees to give all parties involved in the appeal
appropriate written notification of the decision to approve or
deny the appeal that meets specified requirements at
§460.122(g).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: APPEALS

YES

NO

10. Applicant agrees to furnish the disputed service as
expeditiously as the participant's health condition requires if a
determination is made in favor of the participant on appeal, per
§460.122(h).
11. Applicant agrees to maintain, aggregate and analyze information
on appeal proceedings, and use this information in its internal
quality improvement program as specified in §460.122(i).
12. Applicant agrees to inform participants in writing of their
additional appeal rights under Medicare, Medicaid managed care,
or both if the participant is a dual eligible, in accordance with
§460.124(a), §460.124(b) and §460.124(c).

B. In the Documents Section, upload your policies and procedures for the appeals
process. The policies and procedures should specify whether the timeframes for
responding to appeals are calendar days or business days.
Note: This process must be developed in accordance with 42 CFR §460.122.
C. In the Documents Section, upload your policies and procedures regarding participants’
additional appeals rights under Medicare and/or Medicaid, including the process for
filing further appeals. The policies and procedures should specify whether the
timeframes for responding to appeals are calendar days or business days.
Note: Policies and procedures must be developed in accordance with 42 CFR
§460.124.

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3.10 Enrollment
The purpose of this section is to ensure that all PACE applicants enroll participants into the
PACE program consistent with the requirements at 42 CFR §460.150, §460.152, §460.154,
§460.156, §460.158, and §460.160.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: ENROLLMENT

YES

NO

1. Applicant agrees to enroll individuals who meet all of the
following eligibility requirements as specified in §460.150(b),
42 CFR §460.150(c) and §460.150(d):
• Is 55 years of age or older;
• Is determined by the SAA to need the nursing facility
services level of care for coverage under the State Medicaid
plan;
• Resides in the PO service area;
• Meets any additional program specific eligibility conditions
imposed under the PACE program agreement; and
• Able to live in a community setting without jeopardizing his
or her health or safety as determined by criteria specified in the
program agreement.
• PACE enrollee may be, but is not required to be, any or all of
the following: (1) entitled to Part A, (2) enrolled under Part B,
(3) Eligible for Medicaid.
2. Applicant agrees to comply with the requirements of
§460.150(d) and not restrict enrollment based on Medicare or
Medicaid eligibility.
3. Applicant agrees that the enrollment agreement minimally
includes the requirements as specified in §460.154.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: ENROLLMENT

YES

NO

4. Applicant agrees that the intake process minimally includes the
following activities for PACE staff and the potential participant,
representative, and/or caregiver as specified in §460.152(a):
• Explains the PACE program, using a copy of the enrollment
agreement described in §460.154;
• Informs participant that PACE is the sole service provider;
• Informs participant that PACE guarantees access to services,
but not access to specific providers;
• Provides a list of employed and most current list of contracted
staff who deliver PACE services;
• Discloses required monthly premium if applicable;
• Discloses Medicaid spend-down obligations if applicable;
• Discloses post-eligibility treatment of income if applicable;
• Requires a signed release form from potential participant to
allow the PACE organization to obtain medical, financial, and
Medicare and Medicaid eligibility information;
• Requires assessment by the SAA to determine eligibility for
nursing facility services (NF) level of care coverage under the
State Medicaid Plan; and
• Requires assessment by the PACE staff to determine if the
potential participant can be cared for appropriately in a
community setting and that the individual meets all PACE
eligibility criteria.
Note: Intake is an intensive process during which PACE staff
members make one or more visits to a potential participant's
residence and the potential participant makes one or more visits
to the PACE center.

5. Applicant agrees to do the following when enrollment is denied
to a prospective participant because his/her health or safety
would be jeopardized by living in the community as specified
in §460.152(b):
• Notify the individual in writing of the reason for the denial;
• Refer the individual to alternative services, as appropriate;
• Maintain supporting documentation of the reason for the
denial; and
• Notify CMS and SAA in the form and manner specified by
CMS and make documentation available for review.
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: ENROLLMENT

YES

NO

6. Applicant agrees to give the enrolled participant the following
items as specified in §460.156(a):
• A copy of the enrollment agreement;
• A PACE membership card; that indicates the individual is a
PACE participant and includes the PACE phone number; and
• Emergency information to be posted in the participant's
residence explaining PACE membership and how to access
emergency services.
7. Applicant agrees to submit participant information to CMS and
SAA in accordance with established procedures as specified in
§460.156(b).
8. Applicant agrees to meet the following requirements when
making necessary changes in the enrollment agreement as
specified in §460.156(c):
• Give an updated copy to the participant; and
• Explain the changes to the participant, caregiver, or
representative in a way they understand.
9. Applicant ensures that the effective date for participant enrollment
in the PACE program is the first day of the calendar month
following the date the PO receives the signed enrollment
agreement as specified in §460.158.
10. Applicant agrees to continue enrollment until the participant's
death, regardless of changes in health status, unless either of the
following actions occur as specified in §460.160(a):
• The participant voluntarily disenrolls; or
• The participant is involuntarily disenrolled in accordance with
PACE regulations.
11. Applicant agrees to cooperate with the annual SAA reevaluation
of the participant's continued need for nursing facility level of care
as required under the State Medicaid plan. If the SAA
permanently waives the requirement due to SAA determination
that there is no reasonable expectation of improvement or
significant change in the participant's condition, applicant agrees
to maintain documentation of SAA waiver and justification in the
participant's medical record as specified in §460.160(b)(1).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: ENROLLMENT

YES

NO

12. Applicant agrees to continue enrollment for the participant who
no longer meets the State Medicaid nursing facility level of care,
if the SAA deems the participant eligible to continue until the next
annual revaluation because the participant reasonably would be
expected to meet the nursing facility level of care requirement
within the next 6 months without continued participation in the
PACE program as specified in §460.160(b)(2).
13. Applicant agrees to work in consultation with the SAA in making
a determination of deemed continued eligibility as specified in
§460.160(b)(3):
• Use the SAA established criteria for "deemed continued
eligibility" which is determined through applying the criteria to a
review of the medical record and plan of care and is specified in
the program agreement.
B. In the Documents Section, upload policies and procedures for eligibility and enrollment,
including the State’s criteria used to determine if individuals are able to live in a
community setting without jeopardizing their health or safety.
Note: The policies and procedures for eligibility and enrollment must be developed in
accordance with 42 CFR §460.150, §460.152, §460.154, §460.156, §460.158, and
§460.160.
C. In the Documents Section, upload any additional enrollment criteria. If not applicable,
please enter N/A in the required document upload template document.
Note: The policies and procedures for eligibility and enrollment must be developed in
accordance with 42 CFR §460.150, §460.152, §460.154, §460.156, §460.158, and
§460.160.
Note: Applicants are to submit a copy of the enrollment agreement, consistent with the
requirements stipulated in §460.154, to the HPMS PACE marketing module for review and
approval.
3.11

Disenrollment

The purpose of this section is to ensure that all PACE applicants voluntarily or involuntarily
disenroll participants and reinstate them in other Medicare and Medicaid Programs, or the
PACE program consistent with the requirements of 42 CFR §460.162 §460.164, §460.166,
§460.168, §460.170, and §460.172.
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A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: DISENROLLMENT

YES

NO

1. Applicant agrees to meet the following requirements regarding
documentation for disenrollment as specified in §460.172:
• Have a policy and procedure in place to document the reasons for
all voluntary and involuntary disenrollments;
• Make documentation available for review by CMS and the SAA;
and
• Use the internal quality improvement program to review
documentation on voluntary disenrollment.
2. Applicant agrees to execute disenrollment for any participant
initiating voluntary disenrollment from the program without cause
at any time as specified in §460.162, effective the first day of the
month following the date the participant's notice of voluntary
disenrollment is received.
3. Applicant agrees that its employees or contractors do not engage in
any practice that would reasonably be expected to have the effect
of steering or encouraging disenrollment of participants due to a
change in health status, per §460.162(c).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: DISENROLLMENT

YES

NO

4. Applicant agrees that involuntary disenrollment of a participant
will only be initiated for any of the following reasons as
specified in §460.164(b) and §460.164(c), and is effective on the
first day of the next month that begins 30 days after the day the
PACE organization sends notice of the disenrollment to the
participant, per §460.164(a):
• Participant, after a 30-day grace period, fails to pay, or to make
satisfactory arrangements to pay, any premium due the PACE
organization;
• Participant, after a 30 day grace period, fails to pay, or make
satisfactory arrangements to pay any applicable Medicaid spend
down liability or any amount due under the post-eligibility
treatment of income process, as permitted under §§460.182 and
460.184;
• Participant moves out of the PACE program service area or is
out of the service area for more than 30 consecutive days, unless
the PO agrees to a longer absence due to extenuating
circumstances;
• Participant is determined to no longer meet the State Medicaid
nursing facility level of care requirements and is no longer
deemed eligible;
• PACE program agreement with CMS and the SAA is not
renewed or is terminated;
• PO is unable to offer health care services due to the loss of
State licenses or contracts with outside providers;
• Participant or participant's caregiver engages in disruptive or
threatening behavior by exhibiting behavior that jeopardizes his
or her health or safety, or the safety of others; and
• Participant with decision-making capacity refuses to comply
with the care plan or terms of the enrollment agreement.
5. Applicant agrees to have a policy and procedure that includes
documentation requirements for disenrollment of a participant
with disruptive or threatening behavior as specified in
§460.164(d) that includes:
• Reason for the proposed involuntary disenrollment; and
• Efforts to remedy the situation.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: DISENROLLMENT

YES

NO

6. Applicant agrees not to involuntarily disenroll a participant who
engages in non-compliant behavior if the behavior (including
repeated non-compliance with medical advice and repeated
failure to keep appointments) is related to a mental or physical
condition unless the behavior jeopardizes his or her health or
safety, or the safety of others as specified in §460.164(e).
7. Applicant agrees to ensure that before an involuntary
disenrollment is effective, the SAA reviewed and determined that
the applicant has adequately documented acceptable grounds for
disenrollment as specified in §460.164(f).
8. Applicant agrees to take the following actions in executing the
disenrollment as specified in §460.166(a), and §460.166(b)(2):
• Use the most expedient process allowed under Medicare and
Medicaid procedures and set forth in the PACE program
agreement;
• Coordinate the disenrollment date between Medicare and
Medicaid (for dual eligible participants);
• Give reasonable advance notice to the participant; and
• Continue to deliver PACE services to the participant until the
date enrollment is terminated.
9. Applicant agrees to establish a disenrollment policy and procedure
to ensure that the participant is aware they must continue to use
PACE services and remain liable for PACE premiums until the
disenrollment is effective as specified in §460.166(b)(1).
10. Applicant agrees to take the following actions to facilitate a
participant's reinstatement in other Medicare and Medicaid
programs after disenrollment as specified in §460.168(a)(b):
• Make appropriate referrals and transmit copies of medical records
to new providers within 30 days; and
• Work with CMS and SAA to reinstate the participant in other
Medicare and Medicaid programs for which the participant is
eligible.
11. Applicant agrees to permit a previously disenrolled participant to
be reinstated in the PACE program as specified in §460.170(a).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: DISENROLLMENT

YES

NO

12. Applicant agrees to reinstate a previously disenrolled participant
with no break in coverage if the reason for disenrollment is failure
to pay the premium, and the participant pays the premium before
the effective date of disenrollment as specified in §460.170(b).
B. In the Documents Section, upload a copy of the Voluntary Disenrollment policies and
procedures.
C. In the Documents Section, upload a copy of the Involuntary Disenrollment policies
and procedures.
3.12

Personnel Compliance

The purpose of this section is to ensure that all PACE applicants have a written plan for
personnel training and competency compliance that is consistent with the requirements of 42
CFR §460.64, §460.66, §460.68, and §460.71.
In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: PERSONNEL
COMPLIANCE

YES

NO

1. Applicant ensures that staff having direct participant contact,
(employed and contracted) meet the following conditions as
specified in §460.64:
• Are legally authorized (e.g., currently licensed, registered, or
certified if applicable) to practice in the state in which they
perform the function or action as evidenced by primary
verification of licenses or certifications;
• Act within the scope of their authority to practice;
• Have one year of experience with a frail or elderly population
or, if the individual has less than 1 year of experience but
meets all other requirements specified in 42 CFR §460.64,
must receive appropriate training from the PACE organization
on working with a frail or elderly population upon hiring;
• Meet a standardized set of competencies for the specific
position description established by the applicant prior to
working independently; and
• Be medically cleared for communicable diseases and have all
immunizations up-to-date prior to engaging in direct
participant contact.
Note: In addition to the qualifications specified above,
applicant ensures that physicians meet the qualifications and
conditions in §410.20.
2. Applicant agrees to provide training to maintain and
improve the skills and knowledge of each staff member with
respect to the individual’s specific duties that results in his
or her continued ability to demonstrate the skills necessary
for the performance of the position as specified in §460.66.
3. Applicant agrees to provide each staff (employed and
contracted) with an orientation that includes, at a minimum,
the organization's mission, philosophy, policies on participant
rights, emergency plan, ethics, the PACE benefit, and any
policies related to the job duties of specific staff as specified
in §460.71(a)(1).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: PERSONNEL
COMPLIANCE

YES

NO

4. Applicant agrees to develop a competency evaluation
program that identifies those skills, knowledge, and abilities
that must be demonstrated by direct participant care staff
(employees and contractors) as specified in §460.71(a)(2).
Applicant also agrees that the competency program must be
evidenced as completed before performing participant care
and on an ongoing basis by qualified professionals as
specified in §460.71(a)(3).
5. Applicant agrees to designate a staff member to oversee the
orientation and competency evaluation programs for
employees and work with the PACE contractor liaison to
ensure compliance by contracted staff as specified in
§460.71(a)(4).
6. Applicant ensures that all staff (employed and contracted)
furnishing direct participant care services meet the following
as specified in §460.71(b):
• Comply with State or Federal requirements for direct patient
care staff in their respective settings;
• Comply with requirements of §460.68(a), regarding persons
with criminal convictions;
• Have verified current certifications or licenses for their
respective positions;
• Are medically cleared for communicable diseases and are
up to date with immunizations before performing direct
patient care;
• Have been oriented to the PACE program; and
• Agree to abide by the philosophy, practices, and protocols
of the PACE organization.
7. Applicant agrees to develop a training program as specified in
§460.71(c) for each personal care attendant to establish the
individual's competency on furnishing personal care services
and specialized skills associated with specific care needs of
individual participants.
Personal care attendants must exhibit competency before
performing personal care services independently as specified in
§460.71(d).

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3.13

Program Integrity

The purpose of this section is to ensure that all PACE applicants employ individuals or
contract with organizations consistent with the requirements of 42 CFR §460.68.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PROGRAM INTEGRITY

YES

NO

1. Applicant agrees to comply with requirements of §460.68 (a) and
attests that it will not employ individuals or contract with
organizations or individuals:
• Who have been excluded from participation in the Medicare or
Medicaid programs;
• Who have been convicted of criminal offenses related to their
involvement in health or social service programs;
• Whose contact with participants would pose a potential risk
because the individual has been convicted of one or more criminal
offenses related to physical, sexual, drug or alcohol abuse or use,
as determined by the PACE organization;
• Who have been found guilty of abusing, neglecting, or
mistreating individuals by a court of law or who have had a finding
entered into the State nurse aide registry concerning abuse, neglect,
mistreatment of residents, or misappropriation of their property; or
• Who have been convicted of specific crimes for any offense
described in section 1128(a) of the Social Security Act.
2. Applicant agrees to comply with requirements of §460.68(b)
regarding identification of members of its governing body or any
immediate family member having a direct or indirect interest in
contracts, and attests that it will have disclosure and recusal
policies and procedures to ensure compliance with §460.68(b) and
(c).

3.14 Contracted Services
The purpose of this section is to ensure that all PACE applicants execute contracts consistent
with the requirements of 42 CFR §460.70, §460.71, §460.80, §460.98, and §460.100.
A. In HPMS, complete the table below:
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: CONTRACTED SERVICES

YES

NO

1. Applicant agrees that the organization will have a written
contract with each outside organization, agency, or
individual that delivers administrative or care-related
services not furnished directly by the PACE organization
except for emergency services as specified in §460.70(a),
and §460.100.
2. Applicant agrees that the organization will only execute a
contract with contractors that meet all applicable Federal and
State requirements including, but not limited to, the following
as specified in §460.70(b)(1), §460.70(b)(2), §460.98, and
§460.100:
• An institutional contractor, such as a hospital or skilled
nursing facility, must meet Medicare or Medicaid participation
requirements;
• A practitioner or supplier must meet Medicare or Medicaid
requirements applicable to the services delivered;
• Contractors must comply with the PACE requirements for
service delivery, participant rights, and quality improvement
activities; and
• Contractors must be accessible to participants and located
either within or near the PO's service area.
3. Applicant agrees that the organization designates an official
liaison to coordinate activities between contractors and the
organization as specified in §460.70(b)(3).
4. Applicant agrees to maintain a current list of all contractors on
file at the PACE center and distribute the list to anyone upon
request as specified in §460.70(c).
5. Applicant agrees to develop an oversight process that the PO
will use to ensure that contracts and contractors meet PACE
program and Federal requirements, inclusive of being HIPAA
compliant.
6. Applicant agrees that each contract contains the requirements as
specified in §460.70(d).
7. Applicant acknowledges it cannot contract with another entity to
furnish PACE Center Services unless it is fiscally sound as
defined in §460.80(a), and has demonstrated competence with
the PACE model as evidenced by successful monitoring by
CMS and the SAA.

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3.15 Required Services
The purpose of this section is to ensure that all PACE applicants provide a benefit package for
PACE participants consistent with the requirements of §460.90, §460.92, and §460.96.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: REQUIRED SERVICES

YES

NO

1. Applicant agrees to provide a PACE benefit package for all
participants, regardless of the source of payment as specified
in §460.92(a), that includes the following:
• All Medicare-covered items and services;
• All Medicaid-covered items and services as specified in the
State's approved Medicaid plan; and
• Other services that the IDT determines are necessary to
improve and maintain the participant's overall health status.
2. Applicant agrees that decisions by the interdisciplinary team
to provide or deny services must be based on an evaluation
of the participant that takes into account (§460.92(b)):
(1) The participant’s current medical, physical, emotional,
and social needs; and
(2) Current clinical practice guidelines and professional
standards of care applicable to the particular service.
3. Applicant agrees to provide a PACE benefit package for all
participants, regardless of the source of payment as specified
in §460.96, that excludes the following:
• Cosmetic surgery, which does not include surgery that is
required for improved functioning of a malformed part of
the body resulting from an accidental injury or for
reconstruction following mastectomy;
• Experimental medical, surgical, or other health procedures;
and
• Services delivered outside the United States (except for
those services furnished in accordance with regulatory
requirements and as permitted under the State's approved
Medicaid Plan).
4. Applicant agrees to provide a benefit package in which
Medicare and Medicaid benefit limitations and conditions
relating to amount, duration, scope of services, deductibles,
copayments, coinsurance, or other cost sharing do not apply,
per §460.90(a).
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5. Applicant agrees that the participant, while enrolled in the
PACE program, must receive Medicare and Medicaid
benefits solely through the PACE organization, per
§460.90(b).

3.16 Service Delivery
The purpose of this section is to ensure that all PACE applicants have a written plan to furnish
care that meets the needs of each participant consistent with the requirements of 42 CFR
§460.98, and §460.102.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: SERVICE
DELIVERY

YES

NO

1. Applicant agrees to be responsible for providing care that
meets the needs of each participant across all care settings, 24
hours a day, every day of the year, and must establish and
implement a written plan to ensure that care is appropriately
furnished, per §460.98(a).

2. Applicant agrees to provide and oversee the provision of
services as specified in §460.98(b):
• Including furnishing comprehensive medical, health, and
social services that integrate acute and long-term care; and
• Delivered in at least the PACE center, the participant
residence, and inpatient facilities to all participants without
discrimination based on race, ethnicity, national origin,
religion, sex, age, sexual orientation, mental or physical
disability, or source of payment.
• Provided as expeditiously as the participant’s health
condition requires, taking into account the participant’s
medical, physical, emotional, and social needs; and
• Document, track and monitor the provision of services across
all care settings in order to ensure the interdisciplinary team
remains alert to the participant’s medical, physical, emotional,
and social needs regardless of whether services are formally
incorporated into the participant's plan of care.
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: SERVICE
DELIVERY

YES

NO

3. Applicant agrees, at a minimum, to provide the following
services at each PACE center as specified in §460.98(c):
• Primary care, including services furnished by a primary care
provider as defined in §460.102(c) and nursing services;
• Social services;
• Restorative therapies including physical therapy and
occupational therapy;
• Personal care and supportive services;
• Nutritional counseling;
• Recreational therapy;
• Meals; and
• Care management by an interdisciplinary care team.

4. Applicant agrees to operate at least one PACE center in or
contiguous to its defined service area that meet the following
conditions as specified in §460.98(d) and §460.98(e):
• Have sufficient capacity to allow routine attendance by
participants;
• Is accessible and has adequate services to meet the needs of
its participants;
• Offers the full range of services with sufficient staff to meet
the needs of participants at each center if the PO operates
more than one center; and
• Have participants attend the center as frequently as the IDT
determines is necessary based upon the preferences and needs
of each participant.
5. Applicant agrees to provide each participant primary medical
care delivered by a PACE primary care provider as specified
in §460.102(c)(1), and §460.102(c)(2) who does the
following:
• Manages the participant's medical situations; and
• Oversees the participant's use and provision of care by
medical specialists and inpatient facilities.
3.17 Infection Control
The purpose of this section is to ensure that all PACE applicants follow accepted policies and
standard procedures with respect to infection control, including at least the standard
precautions developed by the Centers for Disease Control and Prevention and PACE
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applicants have a written plan for infection control that is consistent with the requirements of
42 CFR §460.74.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF
THE FOLLOWING STATEMENTS:
INFECTION CONTROL

YES

NO

1. PACE applicants have a written plan for infection
control that is consistent with the requirements of
§460.74.
2. Applicant agrees to follow, at a minimum, standard
precautions developed by the Centers for Disease
Control and Prevention.
Note: Refer to the following link: http://www.cdc.gov
3. Applicant agrees to establish, implement and maintain an
Infection Control Plan that meets the following
requirements:
(1) Ensures a safe and sanitary environment.
(2) Prevents and controls the transmission of disease and
infection.
4. Applicant assures that its infection control plan includes,
but is not limited to, the following:
(1) Procedures to identify, investigate, control, and prevent
infections in every PACE center and in each participant's
place of residence.
(2) Procedures to record any incidents of infection.
(3) Procedures to analyze the incidents of infection to
identify trends and develop corrective actions related to
the reduction of future incidents.
3.18 Interdisciplinary Team
The purpose of this section is to ensure that all PACE applicants have qualified staff available
to support IDT composition and operations consistent with the requirements of 42 CFR
§460.102.
A. In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: INTERDISCIPLINARY TEAM

YES

NO

1. Applicant ensures that each participant, in order to meet their
individual needs, is assigned to and comprehensively assessed by
an IDT at the attended PACE center as specified in §460.102(a).
2. Applicant ensures that the IDT is composed of at least a Primary
care provider, Registered nurse, Master's-level social worker,
Physical therapist, Occupational therapist, Recreational therapist
or activity coordinator, Dietitian, PACE center manager, Home
care coordinator, Personal care attendant or representative,
Driver or representative as specified in §460.102(b).
(Note: One individual may fill two separate roles on the
interdisciplinary team where the individual meets applicable state
licensure requirements and is qualified to fill the two roles and able to
provide appropriate care to meet the needs of participants.)
3. Applicant ensures that primary medical care is provided by a
PACE primary care provider as defined in §460.102(c)(1) who is
responsible for the following as specified in §460.102(c)(2)):
• Managing participant medical situations; and
• Overseeing the participant use of medical specialists and
inpatient care.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: INTERDISCIPLINARY TEAM

YES

NO

4. Applicant ensures that the IDT and individual IDT members do
the following as specified in §460.102(d):
• Completes initial assessments, periodic reassessments, and
plans of care;
• Coordinates twenty-four hour care delivery;
• Document all recommendations for care or services and the
reason(s) for not approving or providing recommended care or
services, if applicable, in accordance with §460.210(b).
• Regularly inform the IDT of the medical, functional, and
psychosocial condition of each participant;
• Remain alert to pertinent input from any individual with direct
knowledge of or contact with the participant, including the
following: (A) Other team members; (B) Participants; (C)
Caregivers; (D) Employees; (E) Contractors; (F) Specialists;
(G) Designated representatives; and
• Document changes of participant's condition in the medical
record consistent with documentation policies established by
the medical director.
5. Applicant agrees to establish written policies and implement
procedures to safeguard the privacy of any information that
identifies a particular participant consistent with the
requirements for confidentiality per §460.200(e).

3.19

Participant Assessment

The purpose of this section is to ensure that all PACE applicants complete initial
comprehensive participant assessments, reassessments, and unscheduled reassessments
consistent with requirements of 42 CFR §460.104.
A. In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PARTICIPANT ASSESSMENT

YES

NO

1. Applicant ensures that initial participant assessments are
comprehensive, in person, and include, at a minimum
(§460.104(a)(4)):
• Physical and cognitive function and ability;
• Medication use (prescription, over the counter and alternative
medications);
• Participant and caregiver preferences for care;
• Socialization and availability of family support;
• Current health status and treatment needs;
• Nutritional status;
• Home environment including home access and egress;
• Participant behavior;
• Psychosocial status;
• Medical and dental status; and
• Participant language.
2. Applicant ensures that each participant receives an initial face-toface assessment conducted by the following IDT members and
completes the assessment in a timely manner in order to meet the
requirements in §460.104(b):
• Primary care provider;
• Registered nurse;
• Master's level social worker;
• Physical therapist;
• Occupational therapist;
• Recreation therapist or activity coordinator;
• Dietitian;
• Home care coordinator; and
• Other professional disciplines, as recommended by the IDT.
(See §460.104(a)(1), §460.104(a)(2) and §460.104(a)(3).)
3. Applicant ensures that IDT members conducting the initial
assessments promptly consolidate, within 30 days of the date of
enrollment, discipline-specific assessments into a single plan of
care for each participant (§460.104(b)).

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PARTICIPANT ASSESSMENT

YES

NO

4. Applicant ensures that each participant receives a face-to-face
reassessment conducted semiannually by the following IDT
members or more often if the participant's condition dictates
(§460.104(c)):
• Primary care provider;
• Registered nurse;
• Master's level social worker; and
• Other team members that the primary care provider, registered
nurse and Master's-level social worker determine are actively
involved in the development or implementation of the
participant's plan of care.

5. Applicant ensures that IDT members conducting reassessments
promptly complete the following:
• Reevaluate the care plan and discuss changes with the IDT and
participant/caregiver;
• Revise the plan of care and update measurable goals based on
IDT and participant approval;
• Deliver services identified in the revised care plan; and
• Document assessments and any revisions to the plan of care in
the participant medical record.
6. Applicant ensures that the IDT conducts unscheduled
reassessments per requirements at §460.104(d):
• Changes in participant health or status or psychosocial status;
or
• In response to a service determination request the PACE
organization expects to deny or partially deny, in accordance
with §460.121(h).

7. Applicant ensures that semi-annual reassessments are conducted
face-to-face by the applicable IDT members specified in
§460.104(c).
8. Applicant ensures that there are explicit procedures for
performance of unscheduled reassessments as specified in 42
CFR §460.104(d)(1).

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3.20 Plan of Care
The purpose of this section is to ensure that all PACE applicants develop, implement, and
evaluate a plan of care for each participant that is consistent with the requirements of 42 CFR
§460.106.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: PLAN OF
CARE

YES

NO

1. Applicant ensures the integration of discipline-specific
assessments by the IDT into a comprehensive single plan of
care for each participant within 30 days of the date of
enrollment consistent with the requirements of §460.106(a).
2. Applicant ensures that the plan of care satisfies the following,
per §460.106(b):
• Specifies care needed to meet the participant’s medical,
physical, emotional, and social needs identified during
assessment;
• Identifies appropriate interventions for each care need and
how each will be implemented;
• Identifies measurable outcomes to be achieved;
• Utilizes the most appropriate interventions for each care
need that advances the participant toward a measurable
goal and outcome; and
• Identifies how each intervention will be evaluated to
determine progress in reaching specified goals and desired
outcomes.

3. Applicant ensures that the IDT members implement, coordinate
and monitor delivery of all services (direct and contracted and
in all settings) prescribed in the care plan.
4. Applicant ensures that the IDT members continuously update
the care plan as participant health status changes and
communicate changes to all IDT members.
5. Applicant ensures that the IDT reevaluates the goals and
measurable outcomes of each participant's care plan at least
semiannually.

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6. Applicant ensures that the participant and/or caregiver
participate in the development, review, and reevaluation of the
care plan and ensure the participant's concerns are addressed.
7. Applicant ensures that the IDT provides documentation in the
medical record for the following:
• Original plan of care;
• Ongoing changes to the plan of care;
• Participant/caregiver preferences and concerns; and
• IDT discussion that demonstrates collaborative participation
in developing and updating the single comprehensive plan of
care.
3.21

Restraints

The purpose of this section is to ensure that all PACE applicants comply with the physical
and chemical restraint requirements of 42 CFR §460.114.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: RESTRAINTS

YES

NO

1. Applicant agrees to use the least restrictive and most
effective restraint available.
Note: A restraint may be chemical or physical and is
defined in the regulation at §460.114(a).
2. Applicant agrees to restrict the use of restraints to situations
that the IDT determines necessary to ensure the participant's
physical safety or the safety of others.
3. Applicant ensures that restraints are used for a defined,
limited period of time based upon the assessed needs of the
participant in accordance with safe and appropriate
restraining techniques after other less restrictive measures
have been found to be ineffective to protect the participant or
others from harm, and are removed or ended at the earliest
possible time.
4. Applicant ensures that the condition of the restrained
participant is continually assessed, monitored and reevaluated.

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3.22 Physical Environment
The purpose of this section is to ensure that all PACE applicants provide a safely designed
PACE center and maintain equipment consistent with the requirements of 42 CFR §460.72.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PHYSICAL ENVIRONMENT

YES

NO

1. Applicant ensures a PACE center which:
• Is designed, constructed, equipped, and maintained to provide
physical safety for participants, personnel, and visitors; and
• Provides a safe, sanitary, functional, accessible, and
comfortable environment for the delivery of services and
preservation of participant dignity and privacy.
2. Applicant ensures that suitable space and equipment exist to
provide the following:
• Primary medical care and treatment;
• Therapeutic recreation;
• Team meetings;
• Restorative therapies;
• Personal care;
• Socialization activities; and
• Dining services.
3. Applicant ensures that all equipment is maintained according to
manufacturer's recommendations.
4. Applicant ensures the PACE center meets the occupancy
provisions of the current edition of the National Fire Protection
Association's Life Safety Code that apply to the type of setting in
which the center is located.
Note: Exceptions are specified in §460.72(b).
3.23 Emergency and Disaster Preparedness
The purpose of this section is to ensure that all PACE applicants have written plans for
medical and nonmedical emergency care and disaster response that are consistent with the
requirements of 42 CFR §460.84, and §460.100.
A. In HPMS, complete the table below:
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: EMERGENCY AND
DISASTER PREPAREDNESS

YES

NO

1. Applicant agrees to comply with all applicable Federal, State
and local emergency preparedness requirements. This includes
establishing and maintaining an emergency preparedness
program that meets all requirements as specified in §460.84.

2. Applicant ensures that the emergency plan holds harmless CMS,
the State, and the PACE participant if the PACE organization
does not pay for emergency services as specified in
§460.100(a).
3. Applicant agrees to provide for emergency services, both
inpatient and outpatient settings, by a qualified emergency
services provider, other than the PACE organization, or one of its
contract providers, either in or out of the PACE organization’s
service area, in order to evaluate or stabilize an emergency
medical condition as specified in §460.100(b).
4. Applicant ensures that the participant and/or caregiver understand
when and how to get emergency care, and that no prior
authorization is required as specified in §460.100(d).
5. Applicant agrees to provide access to on-call providers 24-hours
a day to consult about emergency services as specified in
§460.100(e)(1).
6. Applicant agrees to provide authorization of urgently needed outof-network services and post-stabilization care services following
emergency services and provide coverage when services are preapproved by the PACE organization, the PACE organization
cannot be contacted, or the PACE organization did not respond to
a request for approval within 1 hour after being contacted as
specified in §460.100(e).
3.24 Transportation Services
The purpose of this section is to ensure that all PACE applicants provide safe and accessible
transportation consistent with the requirements of 42 CFR §460.76.
A. In HPMS, complete the table below:
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: TRANSPORTATION
SERVICES

YES

NO

1. Applicant agrees to provide safe, properly-equipped, and
accessible transportation services to meet the needs of the
participant population at §460.76(a).
2. Applicant agrees to maintain the transportation vehicles it
owns, rents, or leases in accordance with the manufacturer's
recommendations at §460.76(b)(1).
3. Applicant ensures that if the transportation services are
provided by a contractor, the vehicles are maintained in
accordance with the manufacturer's recommendations at
§460.76(b)(2).
4. Applicant ensures that all transportation vehicles are equipped
with an operable hands-free device to communicate with the
PACE center and notify staff when relevant changes in a
participant's health status occur at §460.76(c).
5. Applicant ensures that all transportation personnel
(employed and contracted) receive an initial
orientation and periodic refresher training to manage
participant special needs and emergency situations at
§460.76(d).
6. Applicant agrees, that as part of the IDT process, PO
staff (employees and contractors) must communicate
information and relevant changes in a participant's
care plan to transportation personnel including, but
not limited to, advance directives at §460.76(e).
7. (SAE only) Applicant agrees that the transportation system has
been considered and modified, as necessary, to accommodate
the proposed service area/site expansion.
3.25 Dietary Services
The purpose of this section is to ensure that all PACE applicants provide meals that meet the
participant's daily nutritional and special dietary needs consistent with the requirements of 42
CFR §460.78.
A. In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: DIETARY SERVICES

YES

NO

1. Applicant ensures that meals are nourishing, palatable, wellbalanced, meet recommended daily nutritional content (RDA),
and meet the participant's daily nutritional and special dietary
needs as documented in the participant's assessment and care
plan at §460.78(a).
2. Applicant ensures that each meal will meet the following
requirements consistent with the requirements of §460.78(a):
be prepared by methods that conserve nutritive value, flavor
and appearance; be prepared in a form designed to meet
individual needs; and be prepared and served at the proper
temperature.
3. Applicant agrees to provide substitute foods or nutritional
supplements that meet the daily nutritional and special
dietary needs of any participant who refuses or cannot
tolerate the food served, or does not eat adequately (42 CFR
§460.76(a)(2)).
4. Applicant agrees to provide nutritional support based on
participant condition or diagnosis which include:
• Tube feedings;
• Total parenteral nutrition; and
• Peripheral parenteral nutrition.
(§460.78(a)(3))
5. Applicant agrees to procure foods (including nutritional
supplements and nutrition support items) from sources
approved, or considered satisfactory by Federal, State, Tribal
or local authorities with jurisdiction over the service area of
the organization. Applicant also agrees to store, prepare,
distribute and serve foods (including nutritional supplements
and nutrition support items) and dispose of food under safe
and sanitary conditions.
3.26 Termination
The purpose of this section is to ensure that all PACE applicants have a detailed written
plan for phase-down in the event of termination consistent with the requirements of 42 CFR
§460.50, §460.52, and §460.210.
A. In HPMS, complete the table below:
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: TERMINATIONS

YES

NO

1. Applicant agrees that the following are notified in advance
of termination as specified in §460.50(d):
• Ninety-day advance notice to CMS and the SAA; and
• Sixty-day advance notice to the participant.
2. Applicant agrees to notify the following of termination and
transition procedures in writing as specified in
§460.52(a)(1):
• CMS;
• SAA;
• Community; and
• Participant.
3. Applicant ensures a process to assist participants with the
following as specified in §460.52(a):
• Obtaining reinstatement of conventional Medicare and
Medicaid benefits when terminating;
• Transitioning participant care to other providers when
terminating; and
• Terminating marketing and enrollment activities.
4. Applicant agrees to provide assistance to each
participant in obtaining necessary transitional care
through appropriate referrals and supply new providers
the participant’s medical records, during the process of
terminating the PACE program agreement as specified
in §460.52(b).
B. In the Documents Section, upload your termination plan.
Note: The plan for termination must be developed in accordance with 42 CFR §460.50 and
§460.52.
3.27 Maintenance of Records & Reporting Data
The purpose of this section is to ensure that all PACE applicants maintain records and
submit reports consistent with the requirements of 42 CFR §460.200.
A. In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: MAINTENANCE OF
RECORDS & REPORTING DATA

YES

NO

1. Applicant ensures data collection, record maintenance, and
report submission as required by CMS and the SAA per
§460.200(a).
Note: Reports include those necessary for CMS and the State to
monitor the operation, cost, quality, effectiveness of the
program, and establish payment rates.
2. Applicant ensures CMS and SAA access to data and records
per §460.200(b) including, but not limited to:
• Participant health outcomes data;
• Financial books and records;
• Medical records; and
• Personnel records.
3. Applicant ensures CMS and the SAA are able to obtain,
examine or retrieve participant health outcomes data, which
may include reviewing information at the PACE site or
remotely, and agrees that this may entail uploading or
electronically transmitting information, or sending hard
copies of required information by mail, per §460.200(b)(2).
4. Applicant ensures written policies and implementation of
procedures to safeguard data, books and records against the
following as specified in §460.200(d)(1):
• Loss;
• Destruction;
• Unauthorized use; and
• Inappropriate alteration.
5. Applicant ensures confidentiality of health information, per
§460.200(e), through policies and procedures that do the
following:
• Safeguard privacy and confidentiality of participant health
information, including mental health information, per
HIPAA and other Federal and State laws;
• Maintain complete records in an accurate and timely
manner; and
• Provide participants timely access to review and copy
their own medical records as well as request amendments
to the record.
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6. Applicant ensures retention of records, per §460.200(f), for
the longest of the following periods:
• Time specified in State law;
• Ten years from the last entry date in the record or for
medical records of disenrolled participants, 10 years after
the date of disenrollment; or
• Completion of litigation or associated resolution of
claims, financial management review or audit, if started
before the expiration of the retention period.
3.28 Medical Records
The purpose of this section is to ensure that all PACE applicants maintain medical records
in accordance with accepted professional standards consistent with the requirements of 42
CFR §460.210.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: MEDICAL
RECORDS

YES

NO

1. Applicant agrees to maintain a single, comprehensive medical
record for each participant, in accordance with accepted
professional standards, as specified in §460.210(a).
2. Applicant ensures that the health information management
policy has procedures that govern the maintenance of a single
comprehensive medical record for each participant that is:
• Complete regardless of format (electronic or print);
• Accurately documented;
• Readily accessible to authorized personnel;
• Systematically organized to facilitate review;
• Available to employed or contracted staff; and
• Maintained and housed at the PACE center where the
participant receives services.
3. Applicant ensures that the medical record contains, at a
minimum, all required components specified in
§460.210(b).
4. Applicant agrees to promptly transfer copies of pertinent
medical record information between treatment facilities,
per §460.210(c).

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5. Applicant's medical records are appropriately
authenticated, per §460.210(d), by ensuring the following:
• All entries are legible, clear, complete, and appropriately
authenticated and dated; and
• Authentication must include signatures or a secured
computer entry by a unique identifier of the primary author
who has reviewed and approved the entry.
3.29 Quality Improvement Program
The purpose of this section is to ensure that all PACE applicants take appropriate actions to
improve performance, including the establishment and operation of a quality improvement
program in accordance with 42 CFR §460, Subpart H, §460.200, and §460.202.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: QUALITY
IMPROVEMENT PROGRAM

YES

NO

1. Applicant agrees to do the following as specified in §460.130:
• Develop, implement, maintain and evaluate an effective, datadriven quality improvement program;
• Reflect the full range of services furnished by the PACE
organization; and
• Take action resulting in improvements in its performance in
all types of care; and
• Meet external quality assessment and reporting requirements,
as specified by CMS or the State administering agency, in
accordance with §460.202.

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: QUALITY
IMPROVEMENT PROGRAM

YES

NO

2. Applicant agrees to use data collected through the health
information system to identify areas for improvement in the
delivery of services, quality, and safety across care domains
(PACE center, home, inpatient, outpatient, rehabilitative etc.)
as specified in §460.136 by doing the following:
• Using a set of outcome measures to identify areas of good or
problematic performance;
• Taking actions targeted at maintaining or improving care
based on outcome measures;
• Incorporating improvements into standard practice to sustain
performance;
• Prioritizing performance improvement activities based on
clinical outcomes, prevalence of the problem in the PACE
population, and severity of the problem; and
• Immediately correcting an identified problem that directly or
potentially threatens the health or safety of participants.
3. Applicant agrees that the designated quality improvement
coordinator will do the following as specified in §460.136:
• Coordinate and oversee implementation of the quality
improvement activities; and
• Encourage PACE participants and caregivers to
participate in quality improvement activities, including
providing information about their satisfaction with services.
4. Applicant ensures that the IDT, PACE staff, and contract
providers are involved in the development and
implementation of quality improvement activities and are
aware of the results of these activities as specified in
§460.136.
5. Applicant agrees to have one or more committees with
community input to do the following as specified in
§460.138:
• Evaluate outcome data measuring quality performance;
• Address the implementation of the quality improvement
plan and the results from quality improvement activities;
and
• Provide input related to ethical decision-making on issues
such as end-of-life, participant self-determination, and
other participant health rights and concerns.
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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: QUALITY
IMPROVEMENT PROGRAM

YES

NO

6. Applicant agrees to submit, upon request from CMS and/or
SAA, data to monitor its operations, costs, quality, and
effectiveness of care and to establish payment rates,
specified in §460.200(c).
7. Applicant ensures a health information system to collect,
analyze, integrate, and report data to measure the
organization's performance as specified in §460.202.
8. Applicant agrees to submit data and information pertaining
to its provision of participant care in the manner, and at the
time intervals, specified by CMS and the State
administering agency as specified in §460.202.
9. Applicant ensures a written quality improvement plan as
specified in §460.132.
B. In the Documents Section, upload a copy of the applicant’s quality improvement
plan. Service area expansion applicants are to upload a current description of their
quality improvement program.
Note: The quality improvement plan must be developed in accordance with 42 CFR
§460.132. A quality improvement program must be developed in accordance with 42
CFR §460.134, including requirements in 42 CFR §460.120(f) and 42 CFR
§460.122(i).
3.30 State Attestations
The purpose of this section is to ensure that the state is willing to enter into a PACE
program agreement with the applying entity, or, as applicable, is willing to amend the
program agreement with a PACE organization applying to expand its service area and/or
add a PACE center site, and that it has processes in place to ensure compliance with its
obligations under the program at 42 CFR §460.12(b).
A. In HPMS, complete the table below:

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RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: STATE
ATTESTATIONS

YES

NO

1. (Initial Applicants): Applicant has assurance from the SAA of
the State in which the program is located indicating that the
State considers the entity to be qualified to be a PACE
organization and is willing to enter into a PACE program
agreement with the entity.
1. (SAE Applicants): Applicant has assurance from the SAA of the
state in which the program is located indicating that the state
considers the entity to be qualified to expand its PACE program
and is willing to amend its existing PACE program agreement
with the entity.
B. In the Document Section upload the State Assurances document signed
by an authorized official from the State agency responsible for
administering a PACE program agreement.
Note: The document should include the written name and title of the official and the
name of the State agency.
C. In the Documents Section upload the state’s CMS-approved Medicaid
capitation payment amount, or the methodology used to calculate the
amount, as described in 42 CFR §460.182(b).
Note: If more than one capitation payment is applicable, please identify by cohort. If
using the rate methodology, it must be consistent with the methodology included in the
state plan.
D. In the Documents Section upload a description of the state's procedures for any
adjustment to account for the difference between the estimated number of
participants on which the prospective monthly payment was based and the actual
number of participants in that month, as required at 42 CFR §460.182(d).
E. In the documents section upload a description of the state’s process for enrollment of
participants into the state system, per §460.182(d), including the criteria for deemed
continued eligibility for PACE in accordance with 460.160(b)(3).
F. In the documents section upload a description of the state’s process to oversee the
applicant’s administration of the SAA’s criteria for determining if a potential PACE
enrollee is safe to live in the community at the time of enrollment, per §460.150(c) and
§460.152(b).

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G. In the documents section, upload a description of any information provided by the
State to participants, to include information on how beneficiaries access the State’s
Fair Hearings process.
H. In the documents section upload a description of the state’s process for disenrollment
of participants from the state’s system, per §460.182(d), as well as the process for prior
review of involuntary disenrollments in accordance with §460.164(f).
3.31 Waivers
PACE applicants are permitted to submit waiver requests consistent with 42 CFR §460.26
and 42 CFR §460.28.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: WAIVERS

YES

NO

N/A

1. Applicant is requesting specific modifications or waivers of
certain regulatory provisions as part of this application as
permitted under Section 903 of the Benefits Improvement and
Protection Act (BIPA) of 2000.
2. Applicant ensures that specific modifications or waivers of
certain regulatory provisions as part of this application have
been submitted to the SAA for review, as specified in 42 CFR
460.26.
B. If you are submitting a waiver request in conjunction with your
application, please upload a copy of your waiver request, in the
Documents Section. Your request should include: Identification of the
regulatory section the applicant is requesting to have waived; the
rationale behind the waiver request; if applicable, process(es), policies
and procedures that will be followed to ensure participant care is not
compromised; and a State letter indicating the State's concurrence,
concerns and conditions related to the waiver request. Please note that
the waiver request is reviewed separately from the application process
itself.
3.32 Application Attestation
Applicants are required to upload a completed and signed attestation certifying that all
information and statements made in the application are true, complete, and current to the
best of their knowledge and belief and are made in good faith.
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A. Please upload your application attestation document.
3.33 State Readiness Review
Applicants are required to submit a State Readiness Review of their PACE center.
A. Please upload your State Readiness Review. Note: The State Readiness
Review upload is required for initial PACE applications and SAE
applications that include a new PACE center. The State Readiness
Review may be submitted in response to a request for additional
information if not available at the time of application submission. If
applying for an SAE with no new PACE Center, the upload is not
required.

4 Document Upload Templates
4.1

Governing Body
GOVERNING BODY
NAMES AND CONTACT LIST
[Appendix A of Program Agreement]

(Instruction: Per requirements at 42 CFR §460.62, provide the names and contact
information for members of the Governing Body in the format below. Please note which
member(s) serves as the participant representative.)
1. Name of Program Director:
Telephone Number:
E-mail address:
2. Name of Governing Body/Board of Director contact person:
Telephone Number:
E-mail address:
3. Governing Body members/Board of Directors:

* Serves as participant representative

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4.2

Legal Entity and Organizational Structure
LEGAL ENTITY AND ORGANIZATIONAL STRUCTURE
[Appendix B of Program Agreement]

(Instruction: Describe the organizational structure of the PO, consistent with the
requirements at 42 CFR §460.60, including the relationship to, at a minimum, the governing
body, program director, medical director, and to any parent, affiliate or subsidiary entity.)
4.3

Subordinated/Guaranteed Debt

If the applicant has a subordinated/guaranteed debt arrangement, the applicant must
complete the “Subordinated/Guaranteed Debt Attestation” form located at
https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/FSRR.html. This
completed form may be uploaded as part of the fiscal soundness part of the application (see
section 3.4.1).
4.4

Explanation of Rights
EXPLANATION OF RIGHTS
[Appendix D of Program Agreement]

(Instruction: Include a description of the Participant Bill of Rights. This must be consistent
with the requirements at 42 CFR §460.110, §460.112, §460.116, and §460.118. Refer to the
PACE Participant Rights template document, which includes current requirements, at:
https://www.cms.gov/Medicare/Health-Plans/PACE/Overview.)
4.5

Enrollment
ENROLLMENT
[Appendix E of Program Agreement]

(Instruction: Describe policies and procedures for eligibility and enrollment, including the
State's criteria used to determine if individuals are able to live in a community setting
without jeopardizing their health or safety. Note: The policies and procedures for eligibility
and enrollment must be developed in accordance with 42 CFR §460.150, §460.152,
§460.154, §460.156, §460.158, and §460.160.)

4.6

Additional Enrollment Criteria
ADDITIONAL ENROLLMENT CRITERIA
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[Appendix F of Program Agreement]
(Instruction: Describe any additional enrollment criteria. Note: The criteria must be
developed in accordance with 42 CFR §460.150(b)(4). If not applicable, please state.)

4.7

Voluntary Disenrollment
VOLUNTARY DISENROLLMENT
[Appendix G of Program Agreement]

(Instructions: Describe voluntary disenrollment policies and procedures. Note: This process
must be developed in accordance with 42 CFR §460.162, §460.166, §460.168, §460.170,
and §460.172.)
4.8

Involuntary Disenrollment
INVOLUNTARY DISENROLLMENT
[Appendix H of the Program Agreement]

(Instructions: Describe involuntary disenrollment policies and procedures. Note: This
process must be developed in accordance with 42 CFR §460.164, §460.166, §460.168,
§460.170, and §460.172.)
4.9

Grievances
GRIEVANCES
[Appendix I of Program Agreement]

(Instructions: Describe policy and procedure for grievances. Note: This process must be
developed in accordance with 42 CFR §460.120 and should specify whether the timeframes
for responding to grievances are calendar days or business days.)

4.10 Appeals
APPEALS
[Appendix I of Program Agreement]
(Instructions: Describe the policy and procedure for the appeals process. Note: This process
must be developed in accordance with 42 CFR §460.122, and should specify whether the
timeframes referenced are for calendar days or business days.)

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4.11 Additional Appeals Rights
ADDITIONAL APPEALS RIGHTS
[Appendix J of the Program Agreement]
(Instructions: Describe policies and procedures regarding participants’ additional appeals
rights under Medicare and/or Medicaid. Note: This process must be developed in
accordance with 42 CFR §460.124, including the process for filing any further appeals, and
should specify whether the timeframes for responding to appeals are calendar days or
business days.)
4.12 Quality Improvement Program
QUALITY IMPROVEMENT PROGRAM
[Appendix K of Program Agreement]
(Instructions: Initial PACE applicants must provide a detailed description of the quality
improvement plan. Note: The quality improvement plan must be developed in accordance
with 42 CFR §460.132. Service area expansion applicants should provide documentation
that reflects their quality improvement program consistent with requirements at 42 CFR
§460.134, including requirements in 42 CFR §460.120(f) and 42 CFR §460.122(i).)

4.13 Medicare and State Medicaid Capitation Payment
MEDICARE AND STATE MEDICAID CAPITATION PAYMENT
[Appendix M of Program Agreement]
CMS makes a prospective monthly payment to the PO of a capitation amount
for each Medicare participant in the payment area. Based on sections 1894(d)
and 1853(n)(5) of the Act, prospective payments are made up of the pre-ACA
county rate (calculated pursuant to section 1853(k)(1) of the Act), unadjusted
for Indirect Medical Education (IME), and multiplied by the sum of the
individual risk score and the organization frailty score. The following is a brief
description of PACE payment and the differences between PACE payment and
payment for Medicare Advantage plans below.
County Rates
The prospective payment rates for PACE are based on the applicable amount
calculated under section 1853(k)(1) of the Act, unadjusted for IME. 1 In
rebasing years, this rate is the greater of: 1) the county’s FFS rate for the
payment year or 2) the prior year’s applicable amount increased by the payment
1

The applicable amount is the pre-Affordable Care Act rate, which is phased-out under the Affordable Care
Act for Medicare Advantage plans, with transition to a new benchmark methodology finalized nationwide in
CY2017. Pursuant to section 1853(n)(5) of the Act, the applicable amount calculated under section
1853(k)(1) continues to apply for PACE.

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year’s National Per Capita Medicare Advantage Growth Percentage. In nonrebasing years, this rate is the prior year’s applicable amount increased by the
payment year’s National Per Capita Medicare Advantage Growth Percentage.
To determine whether a given year is a rebasing year, and for rules applicable to
specific payment years, refer to the applicable Rate Announcement (available
online at: https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html)
Section 1853(k)(4) of the Act requires CMS to phase out indirect medical
education (IME) amounts from MA capitation rates. PACE programs are
excluded from the IME payment phase out under that section pursuant to
section 1894(d)(3).
Effective CY 2006 and subsequent years for MA organizations, CMS makes
advance monthly per capita payments for aged and disabled enrollees based on
the bidding methodology established by the MMA. See section 1854 of the Act.
POs are not required to bid; however, CMS also makes advance monthly per
capita payments to POs for their enrollees, based on the PACE county
benchmark amounts as the capitation rate.
Risk Adjustment
For the final payment rate, the county rate for the PO is multiplied by the
individual participant risk score. Risk adjustment allows CMS to pay plans for
the risk of the beneficiaries they enroll, instead of an average amount for
Medicare beneficiaries. The individual participant risk score for Medicare
Advantage and PACE is calculated using a CMS–HCC model (community,
long-term institutionalized, End-Stage Renal Disease (ESRD) or new enrollee),
which is published in the annual Announcement of Calendar Year Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter (Rate Announcement).
Section 1894(d)(2) of the Act requires CMS to take into account the frailty of
the PACE population when making payments to POs. Therefore, a frailty factor
is added to each individual’s risk score for PACE payment. Risk adjustment
predicts (or explains) the future Medicare expenditures of individuals based on
diagnoses and demographics. Because risk adjustment may not explain all of
the variation in expenditures for frail community populations, the frailty
adjustment is used to predict the Medicare expenditures of community
populations with functional impairments.
The frailty score added to the beneficiary’s risk score is calculated at the
contract-level, using the aggregate counts of ADLs among HOS-M survey
respondents enrolled in a specific organization who responded to the survey the
prior year. More information regarding the HOS-M can be found in section
10.30 in Chapter 10 of the PACE manual chapter, Quality Assessment and
Performance Improvement, located online at:
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Guidance/Guidance/Manuals/downloads/pace111c10.pdf
Because the CMS-HCC model adequately predicts the costs of beneficiaries
under age 55 or who are among the long-term institutionalized population,
frailty adjustments are added to the risk scores for community-based and shortterm institutionalized enrollees aged 55 and older. Updated frailty factors are
published in the Rate Announcement for the payment year in which they are
first used.
Additional Information
For additional, more detailed information about PACE Medicare payment,
please see the following documents:
•
•
•

Payments to Medicare Advantage Organizations, Chapter 8, Medicare
Managed Care Manual
Risk Adjustment, Chapter 7, Medicare Managed Care Manual
CMS publishes changes to the Medicare Advantage payment
methodologies in the Advance Notice of Methodological Changes for
Medicare Advantage (MA) Capitation Rates and Part C and Part D
Payment Policies (Advance Notice) in mid-February at
http://www.cms.gov/MedicareAdvtgSpecRateStats/ for public comment.
The final payment methodologies are published in the Announcement of
Medicare Advantage Capitation Rates and Medicare Advantage and Part
D Payment Policies and Final Call Letter (Rate Announcement) on the
first Monday in April at the same website.

Medicare Part D
In order for POs to continue to meet the statutory requirement of providing
prescription drug coverage to their enrollees, and to ensure that they receive
adequate payment for the provision of Part D drugs, beginning January 1, 2006,
POs began to offer qualified prescription drug coverage to their enrollees who
are Part D eligible individuals. The MMA did not impact the manner in which
POs are paid for the provision of outpatient prescription drugs to non-part D
eligible PACE participants.
POs are required to annually submit two Part D bids: one for a Plan Benefit
Package (PBP) for dually eligible enrollees and one for a PBP for Medicareonly enrollees. The Part D payment to POs comprises several pieces, including
the risk adjusted direct subsidy, reinsurance payments, and risk sharing. With a
few exceptions, Part D payments are made to POs in the same manner as to
MA-PD and standalone PDP plans. The direct subsidy is risk adjusted.
Payments for eligible enrollees of either PBP will include a low-income
premium subsidy and a low-income cost-sharing subsidy for basic Part D
benefits. Payments for dually eligible enrollees will also include an additional
amount to cover nominal cost sharing amounts (“2% capitation”), and an
additional premium payment in situations where the PO’s basic Part D
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beneficiary premium is greater than the regional low-income premium subsidy
amount.
[Insert CMS approved State Medicaid PACE rates into chart, or insert the methodology
used to calculate the rates. The methodology must be consistent with the methodology in
the state plan.]
Description of Rate (ex. Dual Eligible, Medicaid Only)

Amount of Rate

4.14 State Enrollment/Disenrollment Reconciliation Methodology
STATE ENROLLMENT/DISENROLLMENT RECONCILIATION
METHODOLOGY
[Appendix N of Program Agreement]
(Instructions: Provide a description of the state's procedures for any adjustment to account
for the difference between the estimated number of participants on which the prospective
monthly payment was based and the actual number of participants in that month, as required
at 42 CFR §460.182(d).)
4.15 Termination
TERMINATION
[Appendix O of Program Agreement]
(Instruction: Provide a detailed termination plan. Note: The plan for termination must be
developed in accordance with 42 CFR §460.50 and §460.52.)
4.16 SAA Enrollment Process
SAA ENROLLMENT PROCESS
[Appendix P of Program Agreement]
(Instructions: Provide description of the state’s process for enrollment of participants into
the state system in accordance with 42 CFR §460.182(d), as well as the criteria for deemed
continued eligibility for PACE in accordance with 42 CFR §460.160(b)(3).)
4.17 SAA Oversight of PO Administration of Safety Criteria
SAA OVERSIGHT OF PO ADMINISTRATION OF SAFETY CRITERA
[Appendix Q of Program Agreement]
(Instructions: Provide a description of the state’s process to oversee the applicant’s
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administration of the criteria for determining if a potential PACE enrollee is safe to live in
the community at the time of enrollment, and any associated enrollment denials based on
application of that criteria. Note: The process must be developed in accordance with 42
CFR §460.150(c) and 42 CFR §460.152(b).)
4.18 Information Provided by State to Participants
INFORMATION PROVIDED BY STATE TO PARTICIPANTS
[Appendix R of Program Agreement]
(Instructions: Provide a description of any information provided by the State to participants,
to include information on how beneficiaries access the State’s Fair Hearings process.)

4.19 State Disenrollment Process
STATE DISENROLLMENT PROCESS
[Appendix S of Program Agreement]
(Instructions: Provide a description of the state’s process for disenrollment of participants
from the state’s system in accordance with 42 CFR §460.182(d), as well as the process for
prior review of involuntary disenrollments in accordance with 42 CFR §460.164(f).)
4.20 State Attestations/Assurances Signature Pages
STATE ATTESTATIONS/ASSURANCES SIGNATURE PAGES
[Template for State Attestations/Assurances Document]
The purpose of this section is to ensure that the state is willing to enter into a PACE
program agreement with the entity, and that it has processes in place to ensure compliance
with its obligations under the program. Please upload the following assurances with all
blanks filled in and with the appropriate signature from the State Administering Agency.
State certifies that the entity described in this application is qualified to be a PACE provider
and operate in the proposed geographic service area.
State has elected PACE as part of its Medicaid State Plan which allows for operation of the
applicant within the state.
State of ______________________ is willing to enter into a program agreement with the
applicant.
PACE Center address for this application: _______________________________________
(enter N/A if an expansion application without a new PACE Center)
Service area specific to this application. (Include name of each applicable county and
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specify either full or partial for each. If partial, list all applicable zip codes specific to that
county. For expansion applications, only enter the new service area being added.)
___________________________________________________
For a geographic service area expansion application, State agrees that the existing PACE
center site(s) is adequate to serve PACE participants who reside in the proposed geographic
service area.
State certifies that this PACE Organization will have an enrollment limit of
participants (if state enrollment limit applies).
State agrees to establish a process to ensure that all potential participants, including any
individual who is not eligible for Medicaid, are assessed to determine that he or she needs the
level of care required under the state Medicaid plan for coverage of nursing facility services.
(42 CFR §460.152(a)(3))
State agrees to establish a process to receive participant enrollment information from the
applicant for purpose of enrollment of Medicaid participants into the program. (42 CFR
§460.156 (b))
State agrees to establish a process to ensure that, at least annually, participants will be
evaluated to determine if the participant continues to need the level of care required under the
State Medicaid plan for coverage of nursing facility services. (42 CFR §460.160(b))
State agrees to establish a process that may permanently waive the annual recertification
requirement for a participant if it determines that there is no reasonable expectation of
improvement or significant change in the participant’s condition because of the severity of a
chronic condition or the degree of impairment of functional capacity.
When the state determines a PACE participant no longer meets the State Medicaid nursing
facility level of care requirements, the State agrees to establish a process that may deem
participants to continue to be eligible for PACE until the next annual reevaluation if, in the
absence of continued coverage under the program, the participant reasonably would be
expected to meet the nursing facility level of care requirement within the next 6 months.
The State agrees to establish criteria to use in making the determination of deemed continued
eligibility.
The state agrees to make a determination of continued eligibility in consultation with the
applicant, based on a review of the participant’s medical record and plan of care.
The state agrees to oversee the applicant’s administration of the criteria for determining if a
potential PACE enrollee is safe to live in the community.
State agrees to establish a process to ensure that beneficiaries have access to the State’s Fair
Hearings process as an external appeal avenue.
State agrees that before an involuntary disenrollment is effective, the State administering
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agency will review documentation and determine in a timely manner that the applicant has
adequately documented acceptable grounds for disenrollment. (42 CFR §460.164(f))
State agrees to establish a process to receive participant disenrollment information for
purposes of coordinating the disenrollment date between Medicare and Medicaid. (42 CFR
§460.166)
State agrees to ensure that it will work with CMS and the applicant to reinstate a disenrolled
participant in other Medicaid programs for which the participant is eligible. (42 CFR
§460.168)
State agrees to make a prospective monthly payment to the applicant of a capitation amount
for each participant. (42 CFR §460.182)
State agrees to ensure that the capitation amount:
•
•
•

Is less than what would otherwise have been paid under the state plan if the
participants were not enrolled in PACE
Takes into account the comparative frailty of PACE participants
Is a fixed amount regardless of changes in the participant’s health status

State agrees to establish procedures for the enrollment and disenrollment of participants in
the SAA’s system, including procedures for any adjustment to account for the difference
between the estimated number of participants on which the prospective monthly payment
was based, and the actual number of participants in that month.
State agrees to cooperate with CMS in oversight and monitoring of the operations of the
applicant’s program to ensure compliance with PACE requirements. (42 CFR §460.190 and
42 CFR §460.192)
State agrees that it will ensure that the Medicare benefit requirements are protected for
dually eligible PACE participants upon entering a facility, in accordance with 42 CFR
§460.90, including details on when and how Medicaid share of cost requirements are
imposed.
State certifies that the State Administering Agency will verify that the PACE Organization
has qualified administrative and clinical staff employed or under contract prior to furnishing
services to participants.

Printed name and title

Signature

Date

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4.21 Applicant Attestation
CENTERS FOR MEDICARE AND MEDICAID SERVICES
CENTER FOR MEDICARE
CENTER FOR MEDICAID AND CHIP SERVICES
PROVIDER APPLICATION
PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
NAME OF LEGAL ENTITY

MAILING ADDRESS

TRADE NAME (if different)

AREA CODE TELEPHONE NO. EXTENSION

FAX

CEO OR EXECUTIVE DIRECTOR:
NAME AND TITLE

MAILING ADDRESS

TELEPHONE NUMBER

APPLICANT CONTACT PERSON:
NAME
TITLE
ADDRESS
E-MAIL
FAX
TELEPHONE NUMBER

I certify that all information and statements made in this application are true, complete, and current to the best of
my knowledge and belief and are made in good faith.
Signature, CEO / Executive Director

Date

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READINESS REVIEW REPORT
PACE ORGANIZATION:
H #:
DATE (S) OF REVIEW:
REVIEWER (S) – NAME, TITLE AND DEPARTMENT:
DATE OF COMPLETION:
STATE ADMINISTERING AGENCY:
SAA REPRESENTATIVE SIGNATURE:

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STATE READINESS REVIEW
CMS will only approve applications from potential PACE organizations that satisfy federal requirements as determined based on review
of the PACE application, and have met the requirements of a State Readiness Review (SRR). The SRR is performed by the state at the
applicant’s PACE Center. At the time of the SRR, the entity will not be operational and thus will have no enrolled participants. The
purpose of this review is to determine the organization’s readiness to administer the PACE program and enroll participants. The SRR
will include a minimum set of criteria established by CMS in conjunction with the States. The States are free to add any additional
criteria to the readiness review based on state specific requirements or they deem necessary to help them determine if the applicant: 1)
meets the requirements stipulated in the PACE regulation; 2) has developed policies and procedures consistent with the PACE
regulation; and 3) has appropriate staffing and established contracts necessary to provide all-inclusive, quality care to its participants.
The SRR includes but is not limited to: A review of policies and procedures; the design and construction of the PACE center; emergency
preparedness; the site’s compliance with OSHA, FDA, State and local laws, and adherence to Life Safety Code requirements. There
are several areas of the SRR that defer to state and local laws and regulations for compliance. If the applicant’s state has more stringent
laws and regulations, those laws will apply in place of the federal requirement. However, it is incumbent upon the SRR team to ensure
that their state laws or regulations encompass each of the items identified in the federal requirement.
The state is required to complete a readiness review for new PACE organizations as well as existing PACE organizations that propose
to expand by adding a new PACE center site.
Upon completion of the SRR, the state will be responsible for preparing and submitting a completed SRR report ensuring that all required
areas are met.

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PACE
REGULATION
REQUIREMENT
PHYSICAL
ENVIRONMENT
(§460.72)
I.A.
The PACE Center
must be designed,
constructed,
equipped, and
maintained to
provide for the
physical safety of
participants,
personnel, and
visitors.

READINESS CRITERIA

EVIDENCE OF COMPLIANCE WITH ALL STATE AND
LOCAL BUILDING, FIRE SAFETY AND HEALTH CODES.
Visible evidence of the following:

CRITERIA MET

NOTES

 MET
 NOT MET
 MET
 NOT MET

•

Fire exit system

•

Doorways that provide adequate width to allow easy
access and movement of participants by wheelchair or
stretcher;

 MET
 NOT MET

•

Doorways, hallways and stairways that provide access
free from obstructions at all times;

 MET
 NOT MET

•

Lights and handrails in stairways, corridors, bathrooms,
and at exits used by participants;

 MET
 NOT MET

•

Toilets and stalls in the public bathrooms that are
accessible to allow use by nonambulatory and
handicapped participants, staff and visitors;

 MET
 NOT MET

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PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

•

Evidence of compliance with the ADA (28 CFR Part 36
Title III).

 MET
 NOT MET

•

Facility equipped with call lights for a communication
system that alerts staff of participant problems in
bathrooms, therapy areas, etc.

 MET
 NOT MET

•

Design features to safeguard cognitively impaired clients
who may wander (e.g. fences, door alarms, detector
bracelets, etc.) and evidence the safeguards are
operational.

 MET
 NOT MET

Written plan that outlines scheduled maintenance for the PACE
center to include building maintenance.

 MET
 NOT MET

OTHER (SPECIFY)

 Other (Specify
and Attach)

NOTES

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PACE
REGULATION
REQUIREMENT
I. B.
The PACE Center
must ensure a safe,
functional,
accessible and
comfortable
environment for the
delivery of services
to the participant.

READINESS CRITERIA
EVIDENCE OF CERTIFICATION OR LICENSURE BY THE
STATE OR A RECOGNIZED ENTITY FOR ADULT DAY
CENTERS THAT ENCOMPASSES APPROPRIATE
CRITERIA. Note: If the PACE Center is licensed as an adult
day center by the state, skip to 1.C.

CRITERIA MET

NOTES

 MET
 NOT MET
 N.A.

Evidence of the following:
•

Written policies and procedures for ensuring an
environment that provides privacy and dignity for
participants, i.e. doors for exam rooms, privacy curtains,
appropriate clothing and linen to cover participants
during treatment, etc.;

 MET
 NOT MET

•

Lighting and sound levels in care areas, activity and
dining rooms that are appropriate for individuals with
vision, hearing, and cognitive impairments;

 MET
 NOT MET

•

Proper ventilation;

 MET
 NOT MET

•

Written policies and procedures for an effective pest
control program to control infestations by pests and
rodents not limited to roaches, ants, flies, and mice;

 MET
 NOT MET

•

If applicable, designated areas for smoking that are
clearly marked and limited to participants and staff.

 MET
 NOT MET
 N.A.

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PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

•

Posted signs that prohibit smoking while oxygen therapy
is being administered and clearly designated universal
oxygen signs.

 MET
 NOT MET

•

Written policies and procedures regarding smoking
policies, including how to determine if or when
participants may smoke with or without supervision (if
applicable).

 MET
 NOT MET

•

Written policies and procedures on the proper storage,
handling, and disposal of all chemicals, compounds and
biohazardous waste, including Material Safety Data
Sheets for any chemical, cleaning and medical supplies;

 MET
 NOT MET

•

Equipment stored in a manner to ensure participant’s
safety at all times.

 MET
 NOT MET

OTHER (SPECIFY)

NOTES

 Other (Specify
and Attach)

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PACE
REGULATION
REQUIREMENT
I. C.
The PACE Center
must include
sufficient suitable
space and
equipment to
provide primary
medical care and
suitable space for
team meetings,
treatment,
therapeutic
recreation,
restorative
therapies,
socialization,
personal care, and
dining.

READINESS CRITERIA

CRITERIA MET

NOTES

Evidence of Adequate Space For:
(Adequate space would be determined by the provisions, if any,
that are included in the PACE Center Life Safety Code building
occupancy license, and the projected attendance by participants)
•

Team meetings

 MET
 NOT MET

•

Medical treatment and other care

 MET
 NOT MET

•

Therapeutic recreation

 MET
 NOT MET

•

Restorative therapies

 MET
 NOT MET

•

Socialization

 MET
 NOT MET

•

Personal care

 MET
 NOT MET

•

Dining

 MET
 NOT MET

Evidence of sufficient and maintained equipment for safely
transferring disabled participants on to exam tables and
restorative therapy treatment equipment, such as tubs, beds, etc.

 MET
 NOT MET

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PACE
REGULATION
REQUIREMENT

I. D.
The PACE
organization must
establish,
implement and
maintain a written
plan to ensure that
all equipment is
maintained in
accordance with the
manufacturer’s
recommendations

READINESS CRITERIA

CRITERIA MET

Evidence that all storage areas, including food storage, include
appropriate clearance from floors, ceilings and other structural
elements.

 MET
 NOT MET

OTHER (SPECIFY)

 Other (Specify
and Attach)

A written maintenance plan that identifies the individual
responsible for the implementation and monitoring of the plan,
what logs or records will be required, what equipment is
included, and the maintenance schedules according to
manufacturer’s recommendations.

 MET
 NOT MET

A written plan and monitoring program to check all contracts
related to maintenance agreements.

 MET
 NOT MET

Written policies and procedures to ensure compliance with and
report device related death and serious injuries to the FDA
and/or the manufacturer of the equipment in accordance with the

 MET
 NOT MET

NOTES

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PACE
REGULATION
REQUIREMENT
and keep all
equipment
(mechanical,
electrical, and
patient care) free of
defect. This
includes any
equipment in the
patient’s home.
I.E.
The PACE center
must meet the
occupancy
provisions of the
2000 edition of the
LSC for the type of
setting in which it
is located

READINESS CRITERIA

CRITERIA MET

NOTES

Safe Medical Devices Act of 1990.
Evidence of manufacturer’s manuals for all equipment
(mechanical, electrical, safety/emergency preparedness and
patient care).

 MET
 NOT MET

OTHER (SPECIFY)

 Other (Specify
and Attach)
 MET
 NOT MET

EVIDENCE OF COMPLIANCE WITH THE CURRENT
EDITION OF THE LIFE SAFETY CODE or state code that
CMS determined adequately protects participants and staff.
In addition, have evidence of a:
Fire Alarm System:
• Initiation
• Notification
• Control
• Air condition shutdown
• Automatic release of fire doors held open by magnetic
devices
Staff training and drills specific to the PACE Center
Fire evacuation Plans specific to the PACE Center
Fire Procedures specific to the PACE Center
OTHER (SPECIFY)

 MET
 NOT MET

 Other (Specify
and Attach)

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PACE
REGULATION
REQUIREMENT
I.F.
Establish,
implement, and
maintain
documented
procedures to
manage medical
and nonmedical
emergencies and
disasters that
threaten the health
and safety of
participants, staff,
or visitors.
I.G.
PACE organization
must train all staff
(employees and
contractors) on the
actions necessary to
address different
medical and
nonmedical
emergencies.

READINESS CRITERIA

CRITERIA MET

NOTES

Evidence of:
•

Written policies and procedures to manage medical
emergencies, including responding to DNRs, or any
other advance directives; choking; chest pain; seizures;
stopped breathing or cessation of heart;

 MET
 NOT MET

•

Written policies and procedures(s) for the periodic
examination of all emergency drugs to confirm
expiration date(s) and inventory control;

 MET
 NOT MET

•

Written policies and procedures for staff training and
drills for the PACE Center’s emergency procedures,
including the use of emergency drugs and emergency
equipment;

 MET
 NOT MET

•

At least one staff member during hours the center(s)
have participant’s present will be trained and certified in
Basic Life Support (CPR).

 MET
 NOT MET

•

Verify that emergency drugs and emergency equipment
is readily available, operating, and clean including:
o
o
o
o

 MET
 NOT MET

PORTABLE OXYGEN
AIRWAYS
SUCTION EQUIPMENT
PHARMACEUTICALS APPROPRIATE TO
STABILIZE PARTICIPANTS.

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PACE
REGULATION
REQUIREMENT
I.H.
The PACE Center
must have
emergency
equipment, along
with staff who
know how to use
the equipment at
the center at all
times and
immediately
available to
adequately support
participants until
emergency medical
assistance responds
to the center.

READINESS CRITERIA

CRITERIA MET

•

Written policies and procedures to manage nonmedical
emergencies and any natural disasters affecting the
center’s geographic location, including:

 MET
 NOT MET

•

Method of containment of fire;

 MET
 NOT MET

•

Evacuation plans and routes specific to the PACE
Center;

 MET
 NOT MET

•

Adequate emergency lighting at exits and corridors;

 MET
 NOT MET

•

Plans for power outages, problems with water supply,
and transfer of participants to other sites that meet their
special needs;

 MET
 NOT MET

•

Periodic drills specific to the PACE Center;

 MET
 NOT MET

•

Plan for assuring the health and safety of participants at
home to ensure their continuing care needs will be met;

•

Facility structure and characteristics that will
accommodate an expedient and safe evacuation of staff,
participants, and visitors;

OTHER (SPECIFY)

NOTES

 MET
 NOT MET
 MET
 NOT MET
 Other (Specify
and Attach)

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PACE
REGULATION
REQUIREMENT
INFECTION
CONTROL
(§460.74)
II.
At a minimum, the
PACE Center must
have an infection
control plan that
includes:
A. Procedures
to identify,
investigate, control,
and prevent
infections
in the PACE Center
and in each
participant’s place
of residence;
B. Procedures to
record any
incidents of
infection;
C. Procedures to
analyze the
incidents of
infection, to
identify trends, and

READINESS CRITERIA

CRITERIA MET

NOTES

Written policies and procedures for the investigation, control,
and prevention of infections including:
•

A written OSHA Exposure Control Plan which includes
the Universal Precautions and Bloodborne Pathogen
exposure procedures for staff;

 MET
 NOT MET

•

Vaccinating participants and staff against diseases of
particular concern for the PACE participant and the
PACE Center’s geographic location, i.e. influenza and
pneumonia (are required minimally);

 MET
 NOT MET

•

Initial and ongoing health screening and vaccinations for
staff and participants in accordance with OSHA
regulations (staff) and CDC guidelines for tuberculosis,
Hepatitis B and other communicable diseases.

 MET
 NOT MET

•

Written policies and procedures for the investigation,
evaluation, resolution, and reporting of all incidences of
staff and participant infection.

 MET
 NOT MET

•

Written policies and procedures for maintaining records
of staff and participant infections to include postexposure evaluation, training records, and participant and
staff surveillance reports.

 MET
 NOT MET

83

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
develop corrective
actions related to
the reduction of
future incidents.

READINESS CRITERIA

CRITERIA MET

•

Written policies and procedures for reporting required
communicable diseases to the appropriate federal, state
and local officials.

 MET
 NOT MET

•

Policies and procedures for staff providing direct care to
patients with infection(s);

 MET
 NOT MET

•

Provision of adequate facilities and supplies necessary
for infection control to include:

 MET
 NOT MET

•

Hand washing facilities and supplies;

 MET
 NOT MET

•

Laundry facilities and supplies if conducted at PACE
Center;

 MET
 NOT MET
 N/A

•

Isolation facilities and supplies

 MET
 NOT MET

•

Written policies and procedures for addressing how
laundry will be handled. If the service is contracted out,
written agreements to comply with the requirements.

 MET
 NOT MET

•

Written policies and procedures for the ongoing
monitoring of the contractual agreement provisions for
laundry and waste disposal.

NOTES

 MET
 NOT MET
 NA

84

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

READINESS CRITERIA
•

Written policies and procedures for the appropriate
handling and disposal of all waste products including
blood and urine specimens for outside lab tests and other
biohazardous wastes.

OTHER (SPECIFY)

CRITERIA MET

NOTES

 MET
 NOT MET
 Other (Specify
and Attach)

Transportation
Services (§460.76)
III.
The PACE
organization should
take appropriate
steps to ensure that
participants can be
safely transported
from their homes to
the PACE Center
and to
appointments.
A. Requirements
for the
organization’s
transportation
program include:
1. Maintenance of
transportation
vehicles
according to the

Evidence of appropriate state vehicle inspections.

 MET
 NOT MET

If commercial vehicles (greater than 12 seats, usually) are being
used, a commercial license is required by all drivers.

 MET
 NOT MET

If the service is contracted out, written agreements to comply
with the contract requirements under §460.70.

 MET
 NOT MET
 NA

Written policies and procedures for the ongoing monitoring of
the contractual agreement provisions for transportation services.

 MET
 NOT MET
 NA

Evidence of the ability to provide adequate and safe
transportation of center participants:

 MET
 NOT MET

85

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
manufacturer’s
recommendatio
ns.
2. Transportation
vehicles
equipped to
communicate
with the PACE
Center.
3. Training
transportation
personnel on
the special
needs of
participants and
appropriate
emergency
responses.
4. As a part of the
interdisciplinar
y process,
communicating
relevant
changes in the
participant’s
care plans to
transportation
personnel.

READINESS CRITERIA

CRITERIA MET

•

Sufficient staff

 MET
 NOT MET

•

Written policies and procedures for the training and
monitoring of drivers including:

 MET
 NOT MET

•

Proper transfer of nonambulatory and ambulatory
participants;

 MET
 NOT MET

•

Proper use of equipment needed to transfer and secure
participants;

 MET
 NOT MET

•

Emergency procedures during transfer, transport, and
arrival of participants.

 MET
 NOT MET

•

Ability for communication between the driver and PACE
Center during transportation activities.

 MET
 NOT MET

•

Evidence of written policies and procedures on the
maintenance of vehicles utilized in the transport of
participants.

•

Written policies and procedures for communication
between the interdisciplinary team and the transport staff
regarding the needs of the participants being transported.

•

Written policies and procedures for monitoring the
performance of all drivers.

NOTES

 MET
 NOT MET

 MET
 NOT MET
 MET
 NOT MET

86

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

Dietary Services
(§460.78)
IV.
PACE Center is
required to provide
food that is
nourishing,
palatable, wellbalanced, and
meets acceptable
safety standards:
A. Procure food

READINESS CRITERIA
•

Written policies and procedures regarding smoking or
non-smoking on transportation vehicles, and appropriate
signage based on policy.

•

Written procedures to check or audit for the following
information on the drivers:
• Current driver’s license
• Record of any traffic violations or accidents that may
constitute a potential hazard for the transport of
participants.

CRITERIA MET
 MET
 NOT MET

 MET
 NOT MET

OTHER (SPECIFY)

 Other (Specify
and Attach)

Evidence of certification or licensure from state or local health
agencies for the preparation and/or serving of food (including
the last Department of Health Inspection).

 MET
 NOT MET
 N.A.

Written policies and procedures that ensure the safe
delivery of food and nutritional supplements including:

 MET
 NOT MET

•

Safe procurement of food and nutritional supplements;

NOTES

 MET
 NOT MET
87

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
from sources
approved or
considered
satisfactory by
federal, state, tribal
or local authorities
that have
jurisdiction over
the service area;
B. Store, prepare,
distribute, and
serve food under
sanitary conditions;
C. Dispose of
garbage and refuse
properly

READINESS CRITERIA

CRITERIA MET

•

Safe storage of food and nutritional supplements both
perishable and nonperishable to prevent contamination
(at required temperatures – freezer below 0 degrees F or
below and refrigerator 41 degrees or below);

 MET
 NOT MET

•

Safe handling of food and nutritional supplements;

 MET
 NOT MET

•

Safe preparation of food and medication, including
policies for admixtures;

 MET
 NOT MET

•

Safe and adequate water supply;

 MET
 NOT MET

•

Provisions for substitute foods or nutritional
supplements;

 MET
 NOT MET

•

Safe garbage storage and disposal;

 MET
 NOT MET

•

Training of staff in safe food delivery; and

 MET
 NOT MET

•

Written policies and procedures for emergency food
supplies and emergency nutritional supplements

NOTES

 MET
 NOT MET

88

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

READINESS CRITERIA
Written policies and procedures for dietitian, physician, and
pharmacist involvement to determine the nutritional adequacy of
menus and the caloric and nutritional needs for the participant
population.

CRITERIA MET

NOTES

 MET
 NOT MET

OTHER:

Bill of Rights
(§460.110)
V.
The PACE
organization must
have written
policies and
implement
procedures to
ensure that the
participant, his or
her representative,
and staff
understand their
rights.

Written policies and procedures governing the participant Bill of
Rights including:
•

The parameters on the use of physical or chemical
restraints;

 MET
 NOT MET

•

The reporting of mental or physical abuse or neglect.

 MET
 NOT MET

Written policies and procedures for distributing the Bill of
Rights to the participant and his or her representative upon
enrollment and annually.

 MET
 NOT MET

Written policies and procedures to ensure that the participant,
his or her representative, and staff understand participant rights.

 MET
 NOT MET

The participant PACE Bill of Rights should be in English and
any other principal language of the community and be displayed

 MET
 NOT MET
89

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

Personnel
Qualifications
(§460.64)

READINESS CRITERIA

CRITERIA MET

NOTES

in an area frequented by the public.
Evidence of compliance with State requirement, if any, for
specific criteria of the principal language
The participant Bill of Rights should be in a large print for the
elderly to read.

 MET
 NOT MET

Written policies and procedures to respond to and rectify a
violation of a participant’s rights.

 MET
 NOT MET

OTHER (SPECIFY)

 OTHER
(Specify and
Attach)

90

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
VI.
The PACE Center
must have qualified
staff to provide
care to its frail
elderly participants.

READINESS CRITERIA
Assurance by the State that contracts for all contractors and
contracted personnel are executed by the time the PACE center
becomes operational.

 MET
 NOT MET

Written position descriptions for all staff (employees and
contractors).

 MET
 NOT MET

Assurance by the State that the required members of the
interdisciplinary team (primary care provider, registered nurse,
Master’s-level social worker, PT, OT, recreational therapist or
activities coordinator, dietician, PACE center manager, home
care coordinator, and PACE center personal care attendants,
drivers) are/will be employees or contractors of the PACE center
by the time the PACE center becomes operational.
Evidence that appropriate professional licenses/certifications
have been verified by primary source (licensing/certification
board) and background checks have been done on all staff –
employees and contractors (per state law requirements). If no
direct participant care employees are yet hired then this review
would entail the evidence of the procedures that will be
completed to comply with this area.
OTHER (SPECIFY)

TRAINING AND
COMPETENCY
(§460.66 AND
§460. 71)

CRITERIA MET

NOTES

 MET
 NOT MET

 MET
 NOT MET

 Other (Specify
and Attach)

91

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
VII.
A. The PACE
organization must
provide training to
maintain and
improve the skills
and knowledge of
each staff member
with respect to the
individual’s
specific duties that
results in his or her
continued ability to
demonstrate the
skills necessary for
the performance of
the position.
B. The PACE
organization must
develop a training
program for each
personal care
attendant to
establish the
individual’s
competency in
furnishing personal
care services and
specialized skills

READINESS CRITERIA

CRITERIA MET

NOTES

Written individual competency and training programs for all
team positions, specific to each position that includes at least the
following:
•

•

Competency program to ensure that each staff member
initially and ongoing demonstrates competency in the
skills needed to provide appropriate, culturally
competent care to participants. The competency program
must include:

 MET
 NOT MET

•

Initial hires and ongoing skills demonstration;

 MET
 NOT MET

•

Skills demonstration method of evaluation based on
standard protocols;

 MET
 NOT MET

•

Competent evaluator (including peer evaluator);

 MET
 NOT MET

•

Skills that reflect scope of practice and appropriate
for the PACE Center, home setting and level of care.

 MET
 NOT MET

•

Training should be specific and within the scope of
practice. To include at least the following:

 MET
 NOT MET

Training and demonstrated competency on the transport
of nonambulatory participants for drivers and any other
applicable staff;

 MET
 NOT MET

92

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
associated with
specific care needs
of individual
participants.

READINESS CRITERIA

CRITERIA MET

•

Training and demonstrated competency on all emergency  MET
 NOT MET
equipment and all other equipment necessary for the
performance of his or her specific position;

•

Training and demonstrated competency on center
emergency procedures;

 MET
 NOT MET

•

Training and demonstrated competency on restraint use;

 MET
 NOT MET

•

Training and demonstrated competency on participant
rights, including dignity and privacy, to all participants;

 MET
 NOT MET

•

Training and demonstrated competency in response to
participant grievances or center quality improvement
activities; and

 MET
 NOT MET

•

Training and demonstrated competency in therapeutic
communication specific to the PACE setting and
population.

 MET
 NOT MET

Written training manual for personal care attendants to ensure
that they exhibit competency in basic skills for providing
personal care, including:
•

How to maintain a clean, safe and healthy environment;

NOTES

 MET
 NOT MET
 MET
 NOT MET

93

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

READINESS CRITERIA
•

Appropriate and safe techniques in personal hygiene and
grooming;

 MET
 NOT MET

•

Safe transfer techniques and ambulation;

 MET
 NOT MET

•

Observation, reporting, and documentation of patient
status and the care or service furnished.

 MET
 NOT MET

•

Training in therapeutic communication specific to the
PACE setting and population; and

•

Other elements consistent with their assigned duties.

OTHER (SPECIFY)
GENERAL
PROVISIONS
VIII.
General provisions

CRITERIA MET

Evidence of all current licensure required in the State:
 ADHC
 Home Health
 Clinic
 HMO
 Ambulatory Care Center
 Other - specify

NOTES

 MET
 NOT MET
 MET
 NOT MET
 Other (Specify
and Attach)

 MET
 NOT MET
 N/A

94

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT

General Safety
Requirements

READINESS CRITERIA

CRITERIA MET

Written policies and procedures regarding the safeguarding of
participant data and records according to HIPAA compliance for
security (electronic and paper).

 MET
 NOT MET

Written plans and procedures regarding the confidentiality and
retention of participant health information.

 MET
 NOT MET

Written plan and procedures for all participant reassessments
which include periodic reassessments and reassessments at the
participant or participant representative’s request.

 MET
 NOT MET

Verify the PACE organization’s actual service area.

 MET
 NOT MET

Verify the process the PACE organization has in place to ensure
participant access to care 24 hours a day, 7 days a week.

 MET
 NOT MET

Verify that the PACE organization’s network will include all
required services (through staff or contract) by the time the
PACE Center becomes operational.

 MET
 NOT MET

Evidence of a health information system to collect, analyze, and
report participant data.

 MET
 NOT MET

OTHER (SPECIFY)

 Other (Specify
and Attach)

NOTES

95

OMB Control Number: 0938-1326
Expires: TBD, pending OBM approval
PACE
REGULATION
REQUIREMENT
IX.
Overall PACE
Center safety
requirements

READINESS CRITERIA

CRITERIA MET

Evidence of state pharmacy licensure.

 MET
 NOT MET
 N.A.

Written policies and procedures for narcotic inventory control
and disposal.

 MET
 NOT MET

All Medications are locked in a cabinet, room or cart.

 MET
 NOT MET

Written policies and procedures for refrigerator temperature logs
used for medication and food storage.

 MET
 NOT MET

Written policies and procedures for oxygen storage that is in
compliance with fire safety and FDA laws.

 MET
 NOT MET

Evidence of CLIA certification if the PACE Center is
performing waived lab services on site or in the home, e.g.
glucose meter testing, urine testing, fecal occult testing, blood
testing, cholesterol screening, or hemoglobin or hematocrit
testing.

 MET
 NOT MET

OTHER (SPECIFY)

NOTES

 Other (Specify
and Attach)

96


File Typeapplication/pdf
File TitlePART 1 GENERAL INFORMATION
AuthorEmmanuelle Goodrich
File Modified2022-01-13
File Created2022-01-10

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